Label: SUN BUM PREMIUM SPF 15 SUNSCREEN TANNING- avobenzone, homosalate, octisalate, octocrylene oil
- NDC Code(s): 69039-278-00
- 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
• apply liberally 15 minutes before sun exposure • 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 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
mineral oil, aloe barbadensis leaf extract, prunus armeniaca (apricot) kernel oil, simmondsia chinensis (jojoba) seed oil, prunus amygdalus dulcis (sweet almond) oil, helianthus annuus (sunflower) seed oil, cocos nucifera (coconut) oil, linum usitatissimum (linseed) seed oil, persea gratissima (avocado) oil, argania spinosa kernel oil, macadamia ternifolia seed oil, olea europaea (olive) fruit oil, passiflora edulis seed oil, rosa canina fruit oil, camellia oleifera seed oil, theobroma cacao (cocoa) seed butter, camellia sinensis leaf powder, sclerocarya birrea seed oil, hydrogenated vegetable oil, fragrance
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INGREDIENTS AND APPEARANCE
SUN BUM PREMIUM SPF 15 SUNSCREEN TANNING
avobenzone, homosalate, octisalate, octocrylene oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-278 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 MINERAL OIL (UNII: T5L8T28FGP) ALOE VERA LEAF (UNII: ZY81Z83H0X) APRICOT KERNEL OIL (UNII: 54JB35T06A) JOJOBA OIL (UNII: 724GKU717M) ALMOND OIL (UNII: 66YXD4DKO9) SUNFLOWER OIL (UNII: 3W1JG795YI) COCONUT OIL (UNII: Q9L0O73W7L) LINSEED OIL (UNII: 84XB4DV00W) AVOCADO OIL (UNII: 6VNO72PFC1) ARGAN OIL (UNII: 4V59G5UW9X) MACADAMIA OIL (UNII: 515610SU8C) OLIVE OIL (UNII: 6UYK2W1W1E) PASSIFLORA EDULIS SEED OIL (UNII: F3VOA31UHQ) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) CAMELLIA OIL (UNII: T1PE06G0VE) COCOA BUTTER (UNII: 512OYT1CRR) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-278-00 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/01/2019 Labeler - Sun Bum LLC (028642574)