![JUSTICE BY AUSTRALIAN GOLD BROAD SPECTRUM SPF 50 PINK GLITTER SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]](https://medic.hrt.org//dailymed/images/6633c732-d6fe-b33c-e053-2a91aa0a9e05/58443-0253-4.jpg)
| NDC | 58443-0253-4 |
| Set ID | 6633c732-d6fe-b33c-e053-2a91aa0a9e05 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Prime Enterprises Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Active Ingredients
- Purpose
- Uses
- Warnings
-
Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
-
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice Powder, Aluminum, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyethylene, Polyethylene Terephthalate, Polysilicone-15, Polysorbate 20, Polyurethane-33, Propylene Glycol, Red 34, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water, Yellow 5
- Other Information
- Questions or comments?
- Justice by Australian Gold PINK GLITTER SUNSCREEN LOTION SPF 50 Flamingo Fuit Punch
-
INGREDIENTS AND APPEARANCE
JUSTICE BY AUSTRALIAN GOLD BROAD SPECTRUM SPF 50 PINK GLITTER SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0253 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 27.5 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYURETHANE-34 (40 MPA, TENSILE STRENGTH OF FILM AT BREAK) (UNII: 77KA3O6NNF) D&C RED NO. 34 (UNII: BAN556989E) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) COCOA BUTTER (UNII: 512OYT1CRR) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 1.00-2.00) (UNII: KJ6GWA9DJ0) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) OLIVE OIL (UNII: 6UYK2W1W1E) TEA TREE OIL (UNII: VIF565UC2G) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) ALLANTOIN (UNII: 344S277G0Z) POLYSILICONE-15 (UNII: F8DRP5BB29) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALUMINUM (UNII: CPD4NFA903) N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CARBOMER 980 (UNII: 4Q93RCW27E) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SUNFLOWER OIL (UNII: 3W1JG795YI) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) WATER (UNII: 059QF0KO0R) POLYSORBATE 20 (UNII: 7T1F30V5YH) Product Characteristics Color white (Off-white with Pink shimmer) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0253-4 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/07/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 11/07/2017 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0253) , manufacture(58443-0253) , label(58443-0253) , analysis(58443-0253)
