Label: ULTA BEAUTY BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
- NDC Code(s): 58443-0323-3
- Packager: Prime Enterprises Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 11, 2020
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- Official Label (Printer Friendly)
- 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
Alcohol Denat, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymethylsilsesquioxane, Benzyl Alcohol, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Cyclopentasiloxane, Dehydroacetic Acid, Fragrance, Glycerin, Polyester-8, Rosa Damascena Flower Water, Silica Silylate, Sodium Hyaluronate, Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Water
- Other Information
- Question or comments?
- Ulta Beauty SPF 50 Broad Spectrum Sunscreen
-
INGREDIENTS AND APPEARANCE
ULTA BEAUTY BROAD SPECTRUM SPF 50 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58443-0323 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 46.45 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 37.16 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 25.55 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 27.87 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 92.9 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIBUTYL MALEATE (UNII: 4X371TMK9K) DEHYDROACETIC ACID (UNII: 2KAG279R6R) FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) BENZYL ALCOHOL (UNII: LKG8494WBH) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ALCOHOL (UNII: 3K9958V90M) ASCORBYL PALMITATE (UNII: QN83US2B0N) MIDAMALINE HYDROCHLORIDE (UNII: 4CVP92LH8L) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13) LEVOMENOL (UNII: 24WE03BX2T) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERIN (UNII: PDC6A3C0OX) GREEN TEA LEAF (UNII: W2ZU1RY8B0) 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:58443-0323-3 100 mL in 1 TUBE; Type 0: Not a Combination Product 03/04/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 03/04/2020 Labeler - Prime Enterprises Inc. (101946028) Registrant - Prime Enterprises Inc. (101946028) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 pack(58443-0323) , manufacture(58443-0323) , label(58443-0323) , analysis(58443-0323)
