Label: HYDRATING BODY SUNSCREEN UVA AND UVB BROAD SPECTRUM SPF50- homosalate, octocrylene, octisalate, avobenzone cream
- NDC Code(s): 70157-009-01
- Packager: Baxter Laboratories Pty. Ltd.
- Category: HUMAN OTC DRUG LABEL
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 November 29, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions
- Apply generously and evenly 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10a.m.-2p.m.
- wear long sleeve shirts, pants, hats and sunglasses
- Children under 6 months of age: Ask a doctor
-
INACTIVE INGREDIENT
Inactive ingredients
Water, Beeswax, Isopropryl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Ceteareth-20, Hydroxyacetophenone, Carbomer, Benzyl Alcohol, Phenoxyethanol, Sodium Stearoyl Glutamate, Triethanolamine, Simmondsia Chinensis Seed Oil, Rubus Idaeus Seed Oil, Tocopheryl Acetate, Sodium Hyaluronate, Parfum, Glycerin, Maltodextrin, Aloe Barbadensis Leaf Juice, Terminalia Ferdinandiana Fruit Extract, Citric Acid
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HYDRATING BODY SUNSCREEN UVA AND UVB BROAD SPECTRUM SPF50
homosalate, octocrylene, octisalate, avobenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70157-009 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 6 (UNII: XHK3U310BA) HYALURONATE SODIUM (UNII: YSE9PPT4TH) MALTODEXTRIN (UNII: 7CVR7L4A2D) KAKADU PLUM (UNII: 0ZQ1D2FDLI) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) WATER (UNII: 059QF0KO0R) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) BENZYL ALCOHOL (UNII: LKG8494WBH) TROLAMINE (UNII: 9O3K93S3TK) YELLOW WAX (UNII: 2ZA36H0S2V) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) JOJOBA OIL (UNII: 724GKU717M) RASPBERRY SEED OIL (UNII: 9S8867952A) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70157-009-01 140 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/05/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 12/01/2022 Labeler - Baxter Laboratories Pty. Ltd. (740537709)
