Label: SUN BUM TINTED SUNSCREEN FACE UVA/UVB BROAD SPECTRUM SPF 30- titanium dioxide, zinc oxide lotion
- NDC Code(s): 69039-621-01
- 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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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Uses
- Warnings
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Directions
- shake well before use
- apply liberally 15 minutes before sun exposure.
- reapply:
- after 40 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
cyclopentasiloxane, isopropyl myristate, polyamide-5, stearalkonium hectorite, dimethicone crosspolymer, polysilicone-11, oryza sativa (rice) bran extract, rosemarinus officinalis (rosemary) leaf extract, helianthus annus (sunflower) extract, tocopherol, mica, iron oxides, propylene carbonate, synthetic wax, hydrogen dimethicone, isopropyl titanium triisostearate, aluminum hydroxide, silica silylate, octyldodecyl oleate
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INGREDIENTS AND APPEARANCE
SUN BUM TINTED SUNSCREEN FACE UVA/UVB BROAD SPECTRUM SPF 30
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-621 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 53 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 24 mg in 1 mL Inactive Ingredients Ingredient Name Strength CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) RICE BRAN (UNII: R60QEP13IC) ROSEMARY (UNII: IJ67X351P9) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) TOCOPHEROL (UNII: R0ZB2556P8) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) PROPYLENE CARBONATE (UNII: 8D08K3S51E) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) OCTYLDODECYL OLEATE (UNII: MCA43PK7MH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-621-01 1 in 1 BOX 02/22/2021 1 50 mL 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)
