Label: COCONUT VANILLA BODY BROAD SPECTRUM SPF 50- avobenzone, octisalate, octocrylene spray
- NDC Code(s): 71014-094-01
- Packager: EAI-JR286, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 May 19, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
Directions:
- Apply Liberally 15 minutes before sun exposure
- Hold 4 to 6 inches away from body when spraying
- Children under 6 months of age: Ask a doctor
- Do not spray directly on face and avoid breathing mist
- Spray on hand and and apply to face. Use in a well-ventillated area
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.- 2p.m.
Wear long sleeved shirts, pants, hats and sunglasses
Reapply: After 80 minutes of swimming. Immediately after towel use or at least every 2 hours
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
COCONUT VANILLA BODY BROAD SPECTRUM SPF 50
avobenzone, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71014-094 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 g OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 8 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ALOE VERA LEAF (UNII: ZY81Z83H0X) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) AVOCADO OIL (UNII: 6VNO72PFC1) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71014-094-01 142 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/26/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 05/26/2023 Labeler - EAI-JR286, Inc (827896718)
