NDC | 49967-622-01 |
Set ID | dd9d70e7-ec68-4ad2-a310-b37351011c59 |
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 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
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Inactive ingredients
isododecane, isohexadecane, dimethicone/bis-isobutyl PPG-20 crosspolymer, C12-15 alkyl benzoate, caprylyl methicone, silica silylate, bisabolol, tocopheryl acetate, squalane, caprylic/capric triglyceride, dimethyl isosorbide, solanum lycopersicum (tomato) fruit extract, sesamum indicum (sesame) seed extract, tocopherol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
URBAN DECAY URBAN DEFENSE COMPLEXION PRIMER BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49967-622 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 46 mg in 1 mL Inactive Ingredients Ingredient Name Strength ISODODECANE (UNII: A8289P68Y2) ISOHEXADECANE (UNII: 918X1OUF1E) DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) LEVOMENOL (UNII: 24WE03BX2T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SQUALANE (UNII: GW89575KF9) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) TOMATO (UNII: Z4KHF2C175) SESAME SEED (UNII: 7Y1255HVXR) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49967-622-01 1 in 1 CARTON 02/01/2017 1 30 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 02/01/2017 Labeler - L'Oreal USA Products Inc (002136794) Establishment Name Address ID/FEI Business Operations Cosmax USA, Inc. 010990210 manufacture(49967-622)