Label: LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 TINTED MINERAL SUNSCREEN BROAD SPECTRUM SPF 50- titanium dioxide lotion
- NDC Code(s): 69625-899-01, 69625-899-02
- Packager: Cosmetique Active Production
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated December 20, 2017
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- Active ingredient
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
For sunscreen use:
- shake well before use
- apply generously 15 minutes before sun exposure
- after 40 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 meausures 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
water, isododecane, C12-15 alkyl benzoate, dimethicone, undecane, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum stearate, pentylene glycol, C9-15 fluoroalcohol phosphate, tocopherol, phenoxyethanol, stearic acid, diethylhexyl syringylidenemalonate, PEG-9 polydimethylsiloxyethyl dimethcone, magnesium sulfate, PEG-8 laurate, PEG-9, polyhydroxystearic acid, maltodextrin, benzoic acid, iron oxides, propylene glycol, propylene carbonate, caprylyl glycol, disteardimonim hectorite, cassia alata leaf extract, alumina, aluminum hydroxide
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 TINTED MINERAL SUNSCREEN BROAD SPECTRUM SPF 50
titanium dioxide lotion
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69625-899 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 110 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69625-899-01 1 in 1 CARTON 06/01/2012 06/01/2016 1 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:69625-899-02 1 in 1 CARTON 06/01/2012 06/01/2016 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 06/01/2012 Labeler - Cosmetique Active Production (282658798) Establishment Name Address ID/FEI Business Operations Cosmetique Active Production 282658798 manufacture(69625-899)