Want to Sell Cosmetics in the Philippines? Here's What You Actually Need to Know About FDA

Whether you’re selling skin care, body oils, lip balms, or perfumes—if it’s a cosmetic product and you plan to sell it legally in the Philippines, FDA compliance is required.

But before you get overwhelmed by permits, fees, and regulations, start here:

First, What Kind of Cosmetic Business Are You?

Everything depends on how you operate. Here’s how the FDA classifies cosmetic businesses:

1. Manufacturer

You formulate, compound, and produce the product yourself.

You need an LTO as a Manufacturer.
You must meet GMP standards (Good Manufacturing Practice).
You need an FDA-inspected and approved facility.
You'll prepare a Site Master File (SMF) detailing all your systems.
You must secure a Certificate of Product Notification (CPN) for each product or product variant group.
Costs and complexity are high—but so is control.

2. Trader

You own the brand and sell under your name, but the product is made by someone else (a licensed Toll Manufacturer).

You need an LTO as a Trader.
You must have a Contract Manufacturing Agreement with your supplier.
You file for a Certificate of Product Notification (CPN) per product or variant group.
This is the most cost-effective and scalable way to start.

3. Distributor

You resell ready-made products from another company or import finished goods.

You need an LTO as a Distributor.
You must ensure each product already has a valid CPN or Certificate of Product Registration (CPR) depending on the category.
CPR is generally required for products considered borderline drugs or with therapeutic claims (e.g., anti-acne, whitening with actives, SPF claims).
You’re responsible for documentation and post-market surveillance.

Before You Sell Anything: You Must Register Each Product

An FDA LTO allows you to legally operate your business—but it’s not enough. You also need to register each product you intend to sell in the market.

The FDA wants to ensure that:

Products are safe and free from harmful substances
Claims are backed by appropriate classification and data
Products are traceable in case of recalls or safety issues

If you skip this step, you risk your listings being removed from Shopee, Lazada, TikTok, and even being flagged at customs for import violations.

That’s where product registration comes in—and depending on your product type, it falls under CPN or CPR.

CPN vs CPR: What's the Difference?

CPN (Certificate of Product Notification) is required for cosmetic products. It is a relatively simple declaration process. Most cosmetics fall under this.
CPR (Certificate of Product Registration) is required when your product makes therapeutic claims (e.g., anti-fungal, whitening with actives, anti-acne, SPF). These are treated more like drugs or quasi-drugs and require full product dossiers and clinical data.

If unsure which applies, ask your Toll Manufacturer or regulatory consultant. Submitting under the wrong category can cause delays or rejection.

Registering Products: How to File a CPN

CPN/CPR filing is done via FDA eServices Portal

Requirements include:

Your valid LTO number
Product Information File (PIF)
Product label with required details
List of ingredients using INCI names
Product photo and packaging layout

Timeline: 1–2 weeks (longer if documents are incomplete)

Fee: Approximately ₱1,000–₱2,000 per product (multiple variants allowed in one submission)

Labeling Checklist for Cosmetic Products

The FDA requires the following on your product labels:

Product name and variant
Net content (e.g., 50ml)
List of ingredients (INCI names)
Manufacturer or distributor name and address
Country of origin (for imported goods)
Batch number and expiration date
Usage instructions and warnings (if applicable)

Common Mistakes and Red Flags

These are the top reasons for delays or rejections:

Incorrect or incomplete labels
Using banned ingredients (e.g., mercury, hydroquinone)
Making drug-like claims without complete substantiating documentation
Submitting labels that are vague or missing required info
Filing a CPN under the wrong product category
Not including all necessary attachments in your SMF or PIF
Having different claims on your socials, ecommerce stores

Post-Approval Responsibilities

Once you get your LTO and CPN, you still have to maintain compliance. FDA can audit or inspect you at any time.

Keep all batch records and GMP documentation up to date
Renew your LTO and CPNs on schedule (LTO is valid for 1–3 years)
Report any adverse effects or product complaints
Notify FDA if you change product formulation, labeling, or manufacturing location

Why This Matters

Shopee, Lazada, and TikTok Shop now require FDA registration to list cosmetic products. Importers are getting flagged at customs. And under the Internet Transactions Act, enforcement is getting stricter.

You may have been able to "wing it" before. Now, you can’t.

Strong Advice for Small Brands: Start with a Toll Manufacturer

Here’s the hard truth: If you want to build your own brand, going with an FDA-licensed Toll Manufacturer is the smartest move for 90% of startups.

Why?

You avoid the high costs of setting up a compliant facility.
You skip the complexity of hiring a regulatory team from day one.
You launch faster, with less risk and more flexibility.
You can scale as you grow—and reinvest into your brand instead of infrastructure.

Starting as a full-blown manufacturer sounds appealing—"I want control. I want margins"—until you realize:

You need a facility that meets FDA and GMP standards.
You must hire or contract a QPIRA (Qualified Person in Industry Regulatory Affairs).
You’ll undergo inspections and build documented systems for everything from pest control to waste management.

The cost? Anywhere from Php500,000 to over 3 million pesos before you even sell your first bottle.

Most of that can be avoided when you work with a Toll Manufacturer who already:

Has the facility and staff.
Knows the documentation.
Can help you with compliance, CPN filing, and batch tracking.

You focus on your brand, customers, and marketing. They handle the backend, legally and operationally.

Later, once you’ve grown, you can explore manufacturing in-house. But don’t make it your starting point if you don’t have to.

Final Thoughts

Don’t overbuild too early. Build smart, stay compliant, and grow with control.

If you want help finding a Toll Manufacturer, filing your LTO and CPN, or structuring your brand for growth—Agyle Brands can help.