NDC | 56152-5008-1 |
Set ID | 7d7d17a0-7607-1d70-e053-2a91aa0a564f |
Category | HUMAN OTC DRUG LABEL |
Packager | COSMETIC ENTERPRISES LTD |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
For Sunscreen use:
- Aply 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
-
INACTIVE INGREDIENT
Inactive ingredients: Water, Carthamus Tinctorius (Safflower) Oleosomes, C12-15 Alkyl Benzoate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Phospholipids, Retinyl Palmitate (Vitamin A), Ascorbyl Palmitate (Vitamin C), Tocopheryl Nicotinate, Beta Glucan, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Disodium EDTA, Vanilla Planifola Fruit Extract
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
GUARD SUNSCREEN BROAD SPECTRUM SPF 30
octinoxate, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56152-5008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.5 g in 100 mL Inactive Ingredients Ingredient Name Strength CAPRYLYL GLYCOL (UNII: 00YIU5438U) EDETATE DISODIUM (UNII: 7FLD91C86K) ASCORBYL PALMITATE (UNII: QN83US2B0N) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C) VANILLA (UNII: Q74T35078H) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56152-5008-1 44 mL in 1 CARTON; Type 0: Not a Combination Product 12/20/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/20/2018 Labeler - COSMETIC ENTERPRISES LTD (017701475) Registrant - COSMETIC ENTERPRISES LTD (017701475) Establishment Name Address ID/FEI Business Operations COSMETIC ENTERPRISES LTD 017701475 manufacture(56152-5008)