Label: SKIN BALANCING ULTRA SHEER DAILY DEFENCE SPF 30 PAULAS CHOICE- avobenzone, homosalate, octocrylene, oxybenzone cream
- NDC Code(s): 56152-5001-1, 56152-5001-2
- Packager: Cosmetic Enterprises Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 19, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- Apply liberally 15 minutes before sun exposure
- Use a water-resistant sunscreen if swimming or sweating:
- Imeediately after towel drying
- At least every two hours
- Children under 6 months of age: Ask a doctor
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 10AM - 2PM
- Wear long-sleeve shirts, pants, hats and sunglasses
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INACTIVE INGREDIENT
Water (Aqua), Butylene Glycol, Silica, Aluminum Starch Octenylsuccinate, Cetyl Dimethicone, Camelia Sinensis (Green Tea) Leaf Extract, Aloe Barbadensis Leaf Juice Powder, Ascorbyl Palmitate, Phospholipids, Superoxide Dismutase, Adenosine, Tocopherol, Bisabolol, Boerhavia Diffusa Root Extract, Colloidal Oatmeal, Panthenol, Ginkgo Biloba Leaf Extract, Salix Alba (Willow) Bark Extract, Acrylate/C10-30 Alkyl Acrylate Crosspolymer, Titanium Dioxide, Sodium Hydorxide, Steareth-21, Steareth-2, Polysorbate 20, Disodium EDTA, Phenoxyethanol, Sorbic Acid
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SKIN BALANCING ULTRA SHEER DAILY DEFENCE SPF 30 PAULAS CHOICE
avobenzone, homosalate, octocrylene, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56152-5001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 7 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ASCORBYL PALMITATE (UNII: QN83US2B0N) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD) ADENOSINE (UNII: K72T3FS567) TOCOPHEROL (UNII: R0ZB2556P8) LEVOMENOL (UNII: 24WE03BX2T) BOERHAVIA DIFFUSA ROOT (UNII: KR0SR09KYL) OATMEAL (UNII: 8PI54V663Y) PANTHENOL (UNII: WV9CM0O67Z) GINKGO (UNII: 19FUJ2C58T) SALIX ALBA BARK (UNII: 205MXS71H7) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) SODIUM HYDROXIDE (UNII: 55X04QC32I) STEARETH-21 (UNII: 53J3F32P58) STEARETH-2 (UNII: V56DFE46J5) POLYSORBATE 20 (UNII: 7T1F30V5YH) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) SORBIC ACID (UNII: X045WJ989B) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) GREEN TEA LEAF (UNII: W2ZU1RY8B0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56152-5001-1 1.5 mL in 1 PACKET; Type 0: Not a Combination Product 08/12/2016 2 NDC:56152-5001-2 60 mL in 1 TUBE; Type 0: Not a Combination Product 08/12/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 08/12/2016 Labeler - Cosmetic Enterprises Ltd (017701475)
