NDC | 49967-506-01, 49967-506-02, 49967-506-03 |
Set ID | 31c08353-415f-455c-b62a-abac7703bc61 |
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
- Flammable until dry.
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
Directions
For sunscreen use:
● shake well
● apply liberally 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, cyclopentasiloxane, alcohol denat., phenyl trimethicone, glycerin, PEG-10 dimethicone, bis-PEG/PPG-14/14 dimethicone, PEG/PPG/polybutylene glycol-8/5/3 glycerin, rosa gallica flower extract, talc, dimethicone, dimethicone/polyglycerin-3 crosspolymer, methicone, alumina, aluminum hydroxide, magnesium sulfate, disodium stearoyl glutamate, ethylhexyl hydroxystearate, polyethylene glycol, tocopheryl acetate; may contain: red 28 lake, red 7, mica, titanium dioxide, blue 1 lake, bismuth oxychloride, iron oxides
- Questions or comments?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
LANCOME PARIS TEINT MIRACLE LIT FROM WITHIN MAKEUP BROAD SPECTRUM SPF 15 SUNSCREEN
octinoxate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-506 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ALCOHOL (UNII: 3K9958V90M) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE) STANNIC OXIDE (UNII: KM7N50LOS6) ROSA GALLICA FLOWER (UNII: X8W61WUV70) TALC (UNII: 7SEV7J4R1U) DIMETHICONE (UNII: 92RU3N3Y1O) METHICONE (20 CST) (UNII: 6777U11MKT) ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) MAGNESIUM SILICATE (UNII: 9B9691B2N9) DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M) ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LINALOOL, (+/-)- (UNII: D81QY6I88E) LIMONENE, (+)- (UNII: GFD7C86Q1W) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) D&C RED NO. 7 (UNII: ECW0LZ41X8) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) FERRIC OXIDE RED (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-506-01 1 in 1 CARTON 04/01/2011 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:49967-506-02 1 in 1 CARTON 04/01/2011 2 10 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:49967-506-03 110 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/01/2011 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations SICOS ET CIE 276993581 manufacture(49967-506) , pack(49967-506) Establishment Name Address ID/FEI Business Operations BPS60 272259304 pack(49967-506)