NDC | 65912-003-41, 65912-003-43 |
Set ID | b2b6de93-47c8-4b6e-9fb9-8bdc8909271a |
Category | HUMAN OTC DRUG LABEL |
Packager | ELEMIS Limited |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
- apply liberally and evenly 15 minutes before sun exposure and as needed
- children under 6 months of age: Ask a doctor
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin ageing. 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
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- Other information
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Inactive ingredients
Water, Glycerin, Coco-Caprylate, Isostearyl Alcohol, Butylene Glycol Cocoate, Cetyl Alcohol, Phenoxyethanol, Panthenol, Butylene Glycol, Cocos Nucifera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Carbomer, Sodium Stearoyl Glutamate, Chondrus Crispus Powder, Lecithin, 1,2-Hexanediol, Ethylcellulose, Tocopherol, Ethylhexylglycerin, Argania Spinosa Leaf Extract, Carnosine, Tocopheryl Acetate, Disodium EDTA, Sodium Hydroxide, Biosaccharide Gum-4, Melanin, Pentylene Glycol.
- Questions?
- PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton
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INGREDIENTS AND APPEARANCE
DAILY DEFENCE SHIELD SPF 30
avobenzone, octinoxate, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65912-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 14 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 14 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) COCO-CAPRYLATE (UNII: 4828G836N6) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) CETYL ALCOHOL (UNII: 936JST6JCN) PHENOXYETHANOL (UNII: HIE492ZZ3T) PANTHENOL (UNII: WV9CM0O67Z) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) COCONUT OIL (UNII: Q9L0O73W7L) JOJOBA OIL (UNII: 724GKU717M) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) CHONDRUS CRISPUS (UNII: OQS23HUA1X) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B) TOCOPHEROL (UNII: R0ZB2556P8) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ARGANIA SPINOSA LEAF (UNII: 51XV5WTF7E) CARNOSINE (UNII: 8HO6PVN24W) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SODIUM HYDROXIDE (UNII: 55X04QC32I) BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90) MELANIN SYNTHETIC (TYROSINE, PEROXIDE) (UNII: O0CV1RMR44) PENTYLENE GLYCOL (UNII: 50C1307PZG) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65912-003-41 1 in 1 CARTON 06/04/2018 1 40 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:65912-003-43 40 g in 1 TUBE; Type 0: Not a Combination Product 06/04/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/04/2018 Labeler - ELEMIS Limited (399838895)