NDC | 49967-374-01, 49967-374-02, 49967-374-03 |
Set ID | f296e5ef-728a-4d57-8d65-7d88b1f90f88 |
Category | HUMAN OTC DRUG LABEL |
Packager | L'Oreal USA Products Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
Directions
For sunscreen use:
● apply generously 15 minutes before sun exposure
● reapply:
● after 80 minutes of swimming or sweating
● immediately after towel drying
● at least every 2 hours
● 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
● children under 6 months of age: Ask a doctor
- Other information
-
Inactive ingredients
water, C12-15 alkyl benzoate, propylene glycol, diisopropyl sebacate, styrene/acrylates copolymer, glycerin, alcohol denat., dimethicone, potassium cetyl phosphate, acrylates copolymer, ammonium polyacryloyldimethyl taurate, caprylic/capric triglyceride, caprylyl glycol, diethylhexyl syringylidenemalonate, disodium EDTA, glyceryl stearate, hydroxypropyl methylcellulose, isopropyl lauroyl sarcosinate, myristic acid, palmitic acid, PEG-100 stearate, PEG-8 laurate, pentylene glycol, phenoxyethanol, sodium chloride, stearic acid, t-butyl alcohol, tocopherol, triethanolamine
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS DERMO KIDS GENTLE FACE AND BODY BROAD SPECTRUM SPF 60 SUNSCREEN WATER RESISTANT 80 MINUTES
avobenzone, homosalate, octisalate and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-374 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 70 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-374-01 200 mL in 1 TUBE; Type 0: Not a Combination Product 11/01/2016 2 NDC:49967-374-02 300 mL in 1 TUBE; Type 0: Not a Combination Product 11/01/2016 3 NDC:49967-374-03 3 mL in 1 PACKET; Type 0: Not a Combination Product 11/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/01/2016 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations L'Oreal USA, Inc. 185931458 manufacture(49967-374)