Label: SIGNATURE SPF 50 CLEAR FACE- homosalate, octocrylene, octisalate, titanium dioxide, zinc oxide stick
- NDC Code(s): 69039-610-01
- 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 March 22, 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 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
- Inactive ingredients
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- Package Labeling:
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INGREDIENTS AND APPEARANCE
SIGNATURE SPF 50 CLEAR FACE
homosalate, octocrylene, octisalate, titanium dioxide, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69039-610 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 42.3 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 70 mg in 1 g Inactive Ingredients Ingredient Name Strength ETHYLHEXYL PALMITATE (UNII: 2865993309) CERESIN (UNII: Q1LS2UJO3A) PARAFFIN (UNII: I9O0E3H2ZE) YELLOW WAX (UNII: 2ZA36H0S2V) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) DIMETHICONE (UNII: 92RU3N3Y1O) ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69039-610-01 1 in 1 BOX 01/01/2020 1 13 g in 1 CARTRIDGE; 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 01/01/2020 Labeler - Sun Bum LLC (028642574)