Label: BONDI SANDS SUNNY DAZE HYDRATING BROAD SPECTRUM SUNSCREEN SPF 50- zinc oxide lotion
- NDC Code(s): 79950-014-01
- Packager: BONDI SANDS (USA) INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 August 25, 2021
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- Drug Facts
- Active Ingredients
- Purpose
- Uses
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply:
- Every 2 hours
- Use a water resistant sunscreen if swimming or sweating.
- 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 10 a.m.- 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
- Children under 6 months: Ask a doctor.
- Other information
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Inactive Ingredients
Water, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Glycerin, Polyhydroxystearic Acid, Cetearyl Alcohol, Phenoxyethanol, Polyurethane-62, Benzyl Alcohol, Saccharide Isomerate, Citric Acid, Propanediol, Lecithin, Xanthan Gum, Sodium Phytate, Ethylhexylglycerin, Trideceth-6, Tocopherol, Alcohol, Helianthus Annuus (Sunflower) Seed Oil, Sodium Citrate, Erythritol, Hibiscus Sabdariffa Fruit Extract, Iron Oxides.
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INGREDIENTS AND APPEARANCE
BONDI SANDS SUNNY DAZE HYDRATING BROAD SPECTRUM SUNSCREEN SPF 50
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79950-014 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 250 mg in 1 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ERYTHRITOL (UNII: RA96B954X6) SODIUM CITRATE (UNII: 1Q73Q2JULR) HIBISCUS SABDARIFFA WHOLE (UNII: UH3Z91Y49Y) FERRIC OXIDE RED (UNII: 1K09F3G675) SUNFLOWER OIL (UNII: 3W1JG795YI) PROPANEDIOL (UNII: 5965N8W85T) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) PHYTATE SODIUM (UNII: 88496G1ERL) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) TOCOPHEROL (UNII: R0ZB2556P8) BENZYL ALCOHOL (UNII: LKG8494WBH) SACCHARIDE ISOMERATE (UNII: W8K377W98I) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POLYURETHANE-62 (UNII: TBK645J3J8) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TRIDECETH-6 (UNII: 3T5PCR2H0C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79950-014-01 1 in 1 CARTON 08/25/2021 1 50 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/25/2021 Labeler - BONDI SANDS (USA) INC. (117596864)