Label: SAND SKY AUSTRALIAN SUNSHIELD BODY SUNSCREEN SPF50 PLUS lotion
- NDC Code(s): 82931-004-19
- Packager: Supernova USA 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 November 1, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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INDICATIONS & USAGE
Uses
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- Apply an even layer of this lotion on skin 20 minutes before sun exposure.
- Reapply frequently especially after swimming, swaeting, or towelling.
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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 a long-sleeve shirts, pants, hats, and sunglasses.
- Children under 6 months: ask a doctor.
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INACTIVE INGREDIENT
Inactive ingredients Water (Aqua), Bees Wax, Aloe Barbadensis Leaf Juice, Isopropyl Palmitate, Cetearyl Alcohol, Cyclopentasiloxane, Cyclohexasiloxane, Ceteareth-20, Terminalia Ferdinandiana Fruit Extract, Glycerin, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Carbomer, Hydroxyacetophenone, Benzyl Alcohol, Phenoxyethanol, Triethanolamine, Citric Acid.
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SAND SKY AUSTRALIAN SUNSHIELD BODY SUNSCREEN SPF50 PLUS
sand sky australian sunshield body sunscreen spf50 plus lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82931-004 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 OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) YELLOW WAX (UNII: 2ZA36H0S2V) ALOE VERA LEAF (UNII: ZY81Z83H0X) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) BENZYL ALCOHOL (UNII: LKG8494WBH) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERIN (UNII: PDC6A3C0OX) KAKADU PLUM (UNII: 0ZQ1D2FDLI) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color WHITE (white to off-white to light orange pink ) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82931-004-19 1 in 1 CARTON 01/04/2023 1 190 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/04/2023 Labeler - Supernova USA Inc. (116909952) Establishment Name Address ID/FEI Business Operations Baxter Laboratories Pty. Ltd. 740537709 MANUFACTURE(82931-004)
