Label: SUN BUM MINERAL SUNSCREEN FACE STICK SPF 50- zinc oxide stick
- NDC Code(s): 69039-620-01
- 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 ingredient
- 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 Protections Measures- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regurlarly 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
- Other information
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Inactive ingredients
cocos nucifera (coconut) oil, limnathes alba (meadowfoam) seed oil, persea gratiima (avocado) oil, linum usitatissimum (linseed) seed oil, oryza sativa (rice bran) wax, butyloctyl salicylate, ozokerite, butyrospermum parkii (shea) butter, copernicia cerifera (carn-auba) wax, euphorbia cerifera (candelilla) wax, oryzanol, theobroma cacoa (cocoa) seed butter, carthamus tinctorius (sufflower) seed oil, jojoba esters, tocopherol, bisabolol
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INGREDIENTS AND APPEARANCE
SUN BUM MINERAL SUNSCREEN FACE STICK SPF 50
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-620 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 192 mg in 1 g Inactive Ingredients Ingredient Name Strength CERESIN (UNII: Q1LS2UJO3A) COCONUT OIL (UNII: Q9L0O73W7L) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) AVOCADO OIL (UNII: 6VNO72PFC1) LINSEED OIL (UNII: 84XB4DV00W) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) SHEA BUTTER (UNII: K49155WL9Y) CARNAUBA WAX (UNII: R12CBM0EIZ) CANDELILLA WAX (UNII: WL0328HX19) ORYZANOL (UNII: SST9XCL51M) COCOA BUTTER (UNII: 512OYT1CRR) SAFFLOWER OIL (UNII: 65UEH262IS) TOCOPHEROL (UNII: R0ZB2556P8) LEVOMENOL (UNII: 24WE03BX2T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-620-01 1 in 1 BOX 02/22/2021 1 13 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 02/22/2021 Labeler - Sun Bum LLC (028642574)