Label: SUN BUM SUNSCREEN OIL SPF 30 WITH COCONUT OIL- avobenzone, homosalate, octisalate, octocrylene oil
- NDC Code(s): 69039-644-01
- Packager: Sun Bum LLC
- 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 February 4, 2022
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- Drug Facts
- Active ingredients
- Uses
- Warnings
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Directions
• shake well before use • hold container 4 to 6 inches from the skin to apply • spray liberally and spread evenly by hand 15 minutes before sun exposure • do not spray directly into face. Spray on hands then apply to face. • do not apply in windy conditions • use in a well-ventilated area • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 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 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
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Inactive ingredients
cocos nucifera (coconut) oil, isoamyl cocoate, butyloctyl salicylate, alcohol denat.(5%) capryloyl glycerin/sebacic acid copolymer, polyster-8, polyamide-8, aloe barbadensis leaf extract, helianthus annuus (sunflower) seed oil, tocopherol, simmondsia chinenesis (jojoba) seed oil, theobroma cacao (cocoa) seed butter
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INGREDIENTS AND APPEARANCE
SUN BUM SUNSCREEN OIL SPF 30 WITH COCONUT OIL
avobenzone, homosalate, octisalate, octocrylene oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-644 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) COCONUT OIL (UNII: Q9L0O73W7L) ISOAMYL COCOATE (UNII: 14OG46E98E) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ALCOHOL (UNII: 3K9958V90M) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A) ALOE VERA LEAF (UNII: ZY81Z83H0X) SUNFLOWER OIL (UNII: 3W1JG795YI) TOCOPHEROL (UNII: R0ZB2556P8) JOJOBA OIL (UNII: 724GKU717M) COCOA BUTTER (UNII: 512OYT1CRR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-644-01 147 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2022 Labeler - Sun Bum LLC (028642574)
