Label: COVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene oil
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Contains inactivated NDC Code(s)
NDC Code(s): 68327-074-01 - Packager: Cover FX Skin Care Inc.
- 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 January 23, 2019
If you are a consumer or patient please visit this version.
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- Active Ingredients
- Use
- Warnings
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Directions
Apply liberally 15 minutes before sun exposure.
Reapply at least every 2 hours.
Use a water resistant sunscreen if swimming or sweating.
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
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Inactive ingredients
Neopentyl Glycol Diheptanoate, Caprylic/Capric Triglyceride, Dimethicone, Butyloctyl Salicylate, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Acrylates/Dimethicone Copolymer, Cocos Nucifera (Coconut) Fruit Extract, Tocopheryl Acetate, Argania Spinosa Kernel Oil, Bisabolol, Salicornia Herbacea Extract.
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INGREDIENTS AND APPEARANCE
COVER FX SPF 30 BOOSTER DROPS BROAD SPECTRUM SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68327-074 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 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength SALICORNIA EUROPAEA (UNII: 6ADL50JAKW) ARGAN OIL (UNII: 4V59G5UW9X) LEVOMENOL (UNII: 24WE03BX2T) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIMETHICONE (UNII: 92RU3N3Y1O) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) COCONUT (UNII: 3RT3536DHY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68327-074-01 1 in 1 BOX 03/01/2019 1 30 mL in 1 BOTTLE, GLASS; 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 03/01/2019 Labeler - Cover FX Skin Care Inc. (202908021)
