NDC | 49967-129-01, 49967-129-02 |
Set ID | 329b48ce-f3cd-44e8-8446-7e51057efb2e |
Category | HUMAN OTC DRUG LABEL |
Packager | L'Oreal USA Products Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredients
- 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
● apply to all skin exposed to the sun [this statement is optional]
● 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, cyclopentasiloxane, alcohol denat., silica dicaprylyl ether, styrene/acrylates copolymer, diethylhexyl syringlyidenemalonate, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexasiloxane, polymethylsilsesquioxane, nylon-12, dicaprylyl carbonate, phenoxyethanol, lauryl PEG/PPG-18/18 methicone, sodium chloride, caprylyl glycol, PEG-8 laurate, caprylic/capric triglyceride, poly C10-30 alkyl acrylate, disteardimonium hectorite, isostearyl alcohol, p-anisic acid, disodium EDTA, cassia alata leaf extract, maltodextrin, dodecene, poloxamer 407
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 60 FACE ULTRA LIGHT FLUID SUNSCREEN BROAD SPECTRUM SPF 60
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-129 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 107.2 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 32.1 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 60 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 38.6 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) ALCOHOL (UNII: 3K9958V90M) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) NYLON-12 (UNII: 446U8J075B) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) PHENOXYETHANOL (UNII: HIE492ZZ3T) LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX) SODIUM CHLORIDE (UNII: 451W47IQ8X) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PEG-8 LAURATE (UNII: 762O8IWA10) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) P-ANISIC ACID (UNII: 4SB6Y7DMM3) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) MALTODEXTRIN (UNII: 7CVR7L4A2D) DODECENE (UNII: WYE669F3GR) POLOXAMER 407 (UNII: TUF2IVW3M2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-129-01 1 in 1 CARTON 06/01/2013 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49967-129-02 1 in 1 CARTON 06/01/2013 2 3 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/01/2013 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Cosmetique Active Production 282658798 manufacture(49967-129) , analysis(49967-129) Establishment Name Address ID/FEI Business Operations Interspray 364829903 pack(49967-129)