How to Launch Private Label Oral Care Brand in Philippines
Building a private-label oral care line in the Philippines is absolutely doable if you (1) pick the right SKU set, (2) follow the ASEAN Cosmetic Directive (ACD) route for most products, and (3) partner with a manufacturer that can move fast on formulation, stability, and labeling. In PH, most oral-care cosmetics (toothpaste, mouth rinse, breath/oral spray) follow LTO → Cosmetic Product Notification (CPN) rather than drug CPR, provided you avoid therapeutic/medical claims; labels must meet ACD rules. Recent updates from FDA Philippines keep the ACD framework current, so work off the latest circulars and annexes.
Step 1 — Choose your hero SKUs and claims
Start narrow, then expand:
Fresh-breath line: alcohol-free mouthwash (daily use), compact mouth/“breath” spray for on-the-go.
Toothpaste line: daily whitening, sensitive enamel care (e.g., hydroxyapatite), kid-friendly flavors.
Positioning: stay in cosmetic/beauty-care territory (e.g., “freshens breath,” “helps remove surface stains,” “helps maintain healthy-looking teeth”). Claims must align with ACD cosmetic claims guidance.
Tip: If you want to say anything that sounds like treating or preventing disease (e.g., “treats gingivitis”), you may trigger drug classification and CPR instead of CPN.
Step 2 — Map the regulatory path
A. License to Operate (LTO) — required for the entity that manufactures, imports, or distributes regulated products in PH. Ensure your PH entity or importer holds the correct LTO category for cosmetics.
B. Cosmetic Product Notification (CPN) — for each cosmetic SKU before sale/distribution. FDA PH maintains a public verification portal of notified cosmetics.
C. When does CPR apply? — If your product is classed as a drug (because of active-drug claims), you’ll need a Certificate of Product Registration (CPR) instead of CPN.
D. Labels & dossiers — Follow ACD: product name/function, INCI full ingredient list, net content, batch/lot, MFG/EXP, special precautions, responsible company & address, country of manufacture, and instructions for use; labels must be in English and/or a language understood by consumers in PH.
E. Keep an eye on updates — FDA Philippines issued changes amending the ACD in 2025 (e.g., circulars aligning annexes and processes). Always check the latest circular before filing.
Step 3 — Formulation decisions that sell
Alcohol-free mouthwash / spray: consumer-friendly and retail-safe; check preservatives and restricted ingredients against ACD annexes.
Hydroxyapatite (HAp) toothpaste for sensitivity/repair-style cosmetic claims; align wording with ACD cosmetic-claims principles.
Flavor localizations: mint × calamansi/pandan/dalandan resonate locally (cosmetic flavors—no functional health claims).
Abrasivity control: for toothpastes, stay within accepted RDA/REA practice and relevant standards during development.
Step 4 — Packaging & labeling built for retail
On-pack hierarchy: benefit in 3 seconds (“Long-lasting Freshness”), then sensory (“Alcohol-Free • Sugar-Free”), then proof points (GMP/ISO, cruelty-free where applicable).
Compliance microcopy: INCI list, precautions, lot/MFG/EXP, responsible company, country of origin—per ACD.
Formats: 250–500 mL mouthwash, 50–75 mL travel, 10–20 mL spray, 90–120 g toothpaste; tamper-evidence where feasible.
Step 5 — Costing, MOQ, and lead times
MOQs (indicative): 3k–10k units/SKU depending on pack type and flavor rotation.
Development: 2–6 weeks bench work + compatibility; stability often 8–12 weeks accelerated (run in parallel with artwork to save time).
Regulatory filing: LTO lead times vary; CPN is faster than CPR. (Confirm current SLA before scheduling launch.)
Step 6 — Channel strategy for PH
Drugstore chains: Watsons, Mercury Drug → prioritize alcohol-free mouthwash and sensitive/whitening toothpastes.
Convenience & groceries: 7-Eleven/Ministop/SM → push travel sizes and sprays near checkout.
E-commerce: Lazada/Shopee bundles (toothpaste + spray), review-seeding plan, and auto-rebuy coupons.
Social commerce: TikTok Shop—short demos (spray distance, instant mint test), UGC duets, and limited-time flavors.
Step 7 — Ops & QA you shouldn’t skip
ACD ingredient checks against Annex II (bans) and Annex III (restrictions), plus positive lists for preservatives and colorants.
PIF readiness: keep a tidy Product Information File (safety assessment, stability, manufacturing info).
Shelf life target: 24–36 months depending on pack and actives; confirm with real-time data.
Traceability: lot coding that matches your notification records.
Step 8 — Your OEM/ODM partner matters
If you want a turnkey path, Lidercare (our company) provides end-to-end OEM/ODM for oral care, including mouth/breath sprays, mouthwash, toothpastes (e.g., whitening, hydroxyapatite), toothbrushes, whitening strips/kits, pens, foam toothpaste, tablets, pet oral-care, bamboo charcoal, purple toothpaste, and more. We support GMP/ISO manufacturing, safety and stability testing, artwork guidance to meet ACD labeling, and sample-to-pilot-to-mass ramps. We can also align formulations to alcohol-free, sugar-free, vegan-friendly preferences and help with PH LTO/CPN documentation on the manufacturer side. (For Philippine filings, your appointed PH entity/importer remains the local authorization holder as required by FDA rules.)
Step 9 — A straightforward 90-day launch plan
Day 0–15: define SKUs/claims → flavor shortlist → packaging die-lines
Day 16–45: lab samples & sensory → preliminary stability/compatibility → artwork draft
Day 46–60: lock formula/pack → submit LTO (if needed) & CPN dossier prep
Day 61–75: place PO → produce → QA release
Day 76–90: CPN issued → inbound logistics → retail/e-com listing → KOL seeding
(Adjust for your LTO status and any special ingredients.)
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Common pitfalls
Over-claiming: medical-style promises can flip you from CPN to CPR—rewrite to cosmetic claims.
Label gaps: missing INCI, batch, or precautions are common non-compliances—use an ACD checklist.
Ignoring annexes: a restricted preservative at the wrong level will stall launch—recheck Annex III/VI.
No stability window: rushing to ship without accelerated stability risks returns later.
SKU bloat: launch 2–3 winners; add flavors after velocity is proven.
FAQ
1) Are toothpaste and mouthwash “cosmetics” in PH?
Most oral-hygiene products (toothpaste, mouth rinse, breath sprays) are treated as cosmetics under the ACD when claims remain cosmetic; medical/therapeutic claims may reclassify the product as a drug (CPR).
2) Do I need an LTO if I outsource manufacturing?
Yes—the PH entity that imports/distributes needs an appropriate LTO; the manufacturer must also operate under the proper license at their location.
3) What goes on the label?
ACD requires function, INCI list, net content, batch/lot, MFG/EXP, instructions, precautions, responsible company/address, country of manufacture; use English or a locally understood language.
4) How long does CPN take?
Timelines vary; CPN is generally faster than CPR for drugs. Confirm the current SLA with FDA or your consultant before your launch date.
5) Can I sell first online and file later?
No—notify (CPN) first, then sell. The FDA maintains a public CPN verification list.
6) Do I need Filipino on the label?
Labels must be in English and/or a language understood by consumers where the product is marketed (English is acceptable nationwide in PH).
7) How do I make sure ingredients are allowed?
Check ACD annexes: bans (Annex II), restrictions (Annex III), and positive lists for preservatives/colors/UV filters.
Quick checklist
Pick 2–3 hero SKUs & cosmetic-safe claims
Confirm PH LTO holder (your entity or importer)
Formulate to ACD annexes; run stability & compatibility
Build ACD-compliant label (INCI, lot, MFG/EXP, precautions, company, origin)
File CPN per SKU
Lock retail/e-com launch plan (Watsons/Mercury/7-Eleven + Lazada/Shopee/TikTok)
Why brands choose Lidercare for PH private label
Broad oral-care portfolio (sprays, mouthwash, toothpastes, whitening kits/strips, pens, foam toothpaste, tablets, pet oral-care, bamboo charcoal, purple toothpaste, etc.)
Fast sampling → scale manufacturing, GMP/ISO systems, artwork & ACD label support
PH-ready formulations: alcohol-free, sugar-free, sensitive-friendly; local-flavor options
Regulatory coordination support for LTO/CPN with your PH partner entity
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