![ULTA BEAUTY BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]](https://medic.hrt.org//dailymed/images/44aa37e6-e696-022a-e054-00144ff88e88/58443-0244-4.jpg)
| NDC | 58443-0244-4 |
| Set ID | 44aa37e6-e696-022a-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
-
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 INGREDIENT
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Oleifera (Green Tea) Leaf Extract, Caprylyl Glycol, Carbomer, Cucumis Sativus (Cucumber) Extract, Disodium EDTA, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Isopropylphthalimide, Phenoxyethanol, Polyethylene, Polysorbate 20, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water
- Other Information
- Question or comments?
- Ulta Beauty SPF 30 Broad Spectrum Sunscreen
-
INGREDIENTS AND APPEARANCE
ULTA BEAUTY BROAD SPECTRUM SPF 30 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0244 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50.5 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 20.2 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 27.78 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30.3 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 75.75 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) PHENOXYETHANOL (UNII: HIE492ZZ3T) N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E) ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) CAPRYLYL GLYCOL (UNII: 00YIU5438U) COCOA BUTTER (UNII: 512OYT1CRR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) CUCUMBER (UNII: YY7C30VXJT) GREEN TEA LEAF (UNII: W2ZU1RY8B0) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58443-0244-4 177 mL in 1 TUBE; Type 0: Not a Combination Product 12/27/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/27/2016 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0244) , manufacture(58443-0244) , label(58443-0244) , analysis(58443-0244)
