![UNITED SPIRIT OF AMERICA BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]](https://medic.hrt.org//dailymed/images/20d1ae33-e229-55ea-e054-00144ff88e88/58443-0189-3.jpg)
| NDC | 58443-0189-3 |
| Set ID | 20d1ae33-e229-55ea-e054-00144ff88e88 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Prime Enterprises Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Active Ingredients
- PURPOSE
- Uses
- WARNINGS
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Directions
- Apply liberally 15 minutes before sun exposure
- Reapply after 80 minutes of swimming or sweating, immediately after towel drying and 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 a 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 INGREDIENT
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carrageenan, Citric Acid, Diethylhexyl 2,6-Naphthalate, Disodium EDTA, Fragrance, Glyceryl Stearate, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Polyester-8, Polyethylene, Propylparaben, Sorbitol, Stearic Acid, Stearyl Alcohol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water
- Other Information
- United Spirit of American Broad Spectrum SPF 30 Sunscreen
-
INGREDIENTS AND APPEARANCE
UNITED SPIRIT OF AMERICA BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0189 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 19.2 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 19.2 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 72 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 48 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 26.4 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) BUTYLPHTHALIDE (UNII: 822Q956KGM) ALOE VERA LEAF (UNII: ZY81Z83H0X) ALLANTOIN (UNII: 344S277G0Z) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBITOL (UNII: 506T60A25R) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) WATER (UNII: 059QF0KO0R) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) CARRAGEENAN (UNII: 5C69YCD2YJ) COCOA BUTTER (UNII: 512OYT1CRR) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0189-3 85 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/11/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/04/2010 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0189) , manufacture(58443-0189) , label(58443-0189)
