NDC | 49967-422-01, 49967-422-02 |
Set ID | 39e94e53-c34f-46f4-bcf9-e4d5f7a61380 |
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.
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Directions
For sunscreen use:
● apply generously 15 minutes before sun exposure
● reapply at least every 2 hours
● use a water resistant sunscreen if swimming or sweating
● 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, glycerin, butyrospermum parkii (shea) butter, diisopropyl sebacate, C30-45 alkyl dimethicone, dimethicone, butylene glycol, sucrose tristearate, ammonium polyacryloyldimethyl taurate, methylsilanol/silicate crosspolymer, polysorbate 61, fragrance, tocopheryl acetate, sodium stearoyl glutamate, phenoxyethanol, PEG-12 dimethicone, ethylhexylglycerin, tambourissa trichophylla leaf extract, dimethiconol, xanthan gum, caprylyl glycol, disodium EDTA; may contain: mica, iron oxides, titanium dioxide
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ROSALIAC DAILY COMPLETE TONE CORRECTING BROAD SPECTRUM SPF 30 SUNSCREEN CC
octinoxate, octisalate, octocrylene and titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-422 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 30 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 35 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 45 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 62 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) C30-45 ALKYL METHICONE (UNII: NFX970DSI2) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SUCROSE TRISTEARATE (UNII: 71I93STU5M) POLYSORBATE 61 (UNII: X9E1MY2JQG) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-12 DIMETHICONE (UNII: ZEL54N6W95) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) XANTHAN GUM (UNII: TTV12P4NEE) CAPRYLYL GLYCOL (UNII: 00YIU5438U) EDETATE DISODIUM (UNII: 7FLD91C86K) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-422-01 1 in 1 CARTON 08/01/2014 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49967-422-02 1 in 1 CARTON 08/01/2014 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 08/01/2014 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Cosmetique Active Production 282658798 manufacture(49967-422)