Search results for “Product Information File (PIF)”
Products
MoCRA Product Listing — Volume Plans
Under MoCRA, the responsible person must list each cosmetic product with FDA and update listings every year. We prepare and submit listings in Cosm...
View full detailsCosmetic Product Formulation Review
A cosmetic formulation review is an early-stage diagnostic check of a draft or existing formula. It tests whether every ingredient is permitted, us...
View full detailsSafety Data Sheets for HAZMAT Products (USA, CA and AU)
A hazardous SDS for the USA, Canada and Australia, often called a HazMat SDS, is the Safety Data Sheet for a product classified as hazardous under ...
View full detailsAllergen Compliance Check for Cosmetic Products
A fragrance allergen labelling check works out which fragrance allergens in your cosmetic must be named in the ingredient list on your label. Under...
View full detailsSafety Data Sheets for NON HAZMAT Products (USA, CA and AU)
A non-hazardous SDS for the USA, Canada and Australia is a safety data sheet for a product that does not meet the GHS criteria for any health, phys...
View full detailsStability Testing for EU and UK Cosmetic Compliance
Stability testing shows that your cosmetic stays safe and keeps its intended quality in its final packaging over its shelf life. Under Regulation (...
View full detailsThe Formulation Library — 100 Beauty Formulas
The Formulation Library — 100 Beauty Formulas is a 150-page cosmetic formulation e-book for makers and small beauty brands. It gives 100 skincare, ...
View full details30-Minute Expert Consultation for EU, UK and USA Regulations
A cosmetic regulatory consultation is a 30-minute advisory session with a compliance specialist, for brands that need a clear answer on UK, EU or U...
View full detailsFragrance and Cosmetic Products Labelling & Packaging Design
Compliant cosmetic label design is the creation of new label artwork that meets Article 19 of Regulation (EC) No 1223/2009 in the EU and Northern I...
View full detailsSafety Data Sheets for HAZMAT (UK and EU)
A REACH SDS for hazardous products is the safety data sheet that Article 31 of REACH (Regulation (EC) No 1907/2006) requires a supplier to provide ...
View full detailsEU GPSR Compliance for Menstrual & Intimate Hygiene Products
Quick answer Most menstrual and intimate hygiene products are consumer products under the EU General Product Safety Regulation (EU) 2023/988, whic...
View full detailsUS Cosmetic Safety Substantiation File (MoCRA)
MoCRA requires the responsible person to keep records showing adequate safety substantiation for each cosmetic sold in the US. FDA does not prescri...
View full detailsRestricted Ingredients Compliance & Validation
A restricted ingredients check is a focused review of named ingredients in a cosmetic formula against the UK and EU lists of banned and restricted ...
View full detailsFDA MoCRA Product Listing for Cosmetic Products
The US Modernization of Cosmetics Regulation Act of 2022 (MoCRA) requires each facility that manufactures or processes cosmetics for the US market ...
View full detailsFresh Pineapple Musk For Men 1200 Perfume Oil Bulk Fragrance Oil
Quick answer Fresh Pineapple Musk 1200 is a masculine fruity perfume oil sold in bulk from 100 g to 5 kg. Pineapple, blackcurrant, apple and berga...
View full detailsMoCRA Serious Adverse Event Reporting Service
Under MoCRA, the responsible person must report serious adverse events from US cosmetic use to FDA within 15 business days and keep records for 6 y...
View full detailsOTC Drug Establishment Registration + Labeler Code (FDA)
Sunscreens, acne treatments, antiperspirants and other OTC monograph drugs are drugs in the US, not cosmetics. The establishment that makes them mu...
View full detailsFDA Medical Device Classification & Regulatory Pathway Report
Before selling a medical device in the US you need to know its FDA class and whether it needs a 510(k), is exempt, or needs another route. We resea...
View full detailsUS Responsible Person for Cosmetics (12 Months)
Under MoCRA, the responsible person is the company named on a cosmetic's label, with a US address or contact for adverse event reports. Phoenix Saf...
View full detailsOTC Drug Listing with FDA (NDC), per SKU
Each OTC drug sold in the US, such as a sunscreen or acne treatment, must be listed with FDA and carry a National Drug Code. We prepare the drug li...
View full detailsBold Bergamot Pepper Perfume Oil Men 1117 Bulk Fragrance Oil
Quick answer Bold Bergamot Pepper 1117 is a masculine ambroxan perfume oil sold in bulk from 100 g to 5 kg. Bergamot, black pepper and lavender op...
View full detailsCinnamon Amber Spicy Perfumes Unisex 1155
Quick answer Spicy Cinnamon Amber 1155 is a unisex spiced gourmand perfume oil sold in bulk from 100 g to 5 kg. Bergamot and apple open onto cinna...
View full detailsSweet Tobacco Vanilla Perfume Oil For Men 1128
Quick answer Sweet Tobacco Vanilla 1128 is a masculine tobacco perfume oil sold in bulk from 100 g to 5 kg. Bergamot and lemon open onto lavender ...
View full detailsOriental Rose Amber Unisex 1226 Perfume Oil Bulk Fragrance Oil
Quick answer Oriental Rose Amber 1226 is a unisex oriental rose perfume oil sold in bulk from 100 g to 5 kg. Bergamot and Amalfi lemon open onto T...
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