The following Structured Product Label (SPL) was submitted to the FDA by Bcm Cosmetique Sas for the product No 7 Restore And Renew Multi Action Fragrance Free Day Cream Spf 25 (NDC 61589-9102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding warnings, active ingredients, inactive ingredients, uses, directions, storage and handling, otc - questions, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
For extenal use only
Do not use on damaged of broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Avobenzone 3%
Homosalate 7%
Octinoxate 0.8%
Octisalate 5%
Octocrylene 9%
Inactive ingredients
Aqua (Water),Glycerin, Capryloyl glycerin/
sebacic acid copolymer, Propanediol, VP/eicosene copolymer, Butylene glycol,
Tribehenin, Glyceryl stearate, Cetearyl alcohol, PEG-100 stearate, Aluminum starch
octenylsuccinate, Ammonium acryloyldimethyltaurate/VP copolymer,
Phenoxyethanol, Butyrospermum parkii (Shea) butter, Potassium cetyl phosphate,
Polysorbate 20, Pentylene glycol, Caprylyl glycol, Caprylhydroxamic acid, Propylene
glycol, Xanthan gum, Tocopheryl acetate, Ascorbyl glucoside, Hibiscus
abelmoschus extract, Ethylhexylglycerin, Retinyl palmitate, Hydrolyzed hyaluronic
acid, Tetrasodium EDTA, Hydrolyzed rice protein, Sorbitan laurate, Panax ginseng
root extract, Citric acid, Phyllanthus emblica fruit extract, T-butyl alcohol, Potassium
hydroxide, Carbomer, 3-Aminopropane sulfonic acid, Calcium hydroxymethionine,
Hydroxyethylcellulose, Dimethylmethoxy chromanol, Sodium lauroyl lactylate,
Acetyl dipeptide-1 cetyl ester, Morus alba leaf extract, Sodium benzoate,CeramidCeramide NP, Tocopherol, BHT,
Ceramide AP, Phytosphingosine, Cholesterol, Palmitoyl tripeptide-1, Palmitoyl tetrapeptide-7, Ceramide EOP,
CI 14700 (Red 4) *Derivative of
Helps prevent sunburn
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
Children under 6 months of age: Ask a doctor.
Sun Protection Measures
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10 a.m. - 2 p.m.
Wear long-sleeved shirts, pants, hats, and sunglasses
Protect the product in this container from excessive heat and direct sun
Avoid contact with fabrics
Questions? 1-866-75-BOOTS
Active Ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 7% Sunscreen
Octinoxate 0.8% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 9% Sunscrren
Warning
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep Out of Reach of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
* Please review the disclaimer below.
