Label: ALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN- octinoxate, oxybenzone spray
- NDC Code(s): 61477-216-26
- Packager: Aloe Care International, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 13, 2024
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- ACTIVE INGREDIENTS:
- PURPOSE:
- USES
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DIRECTIONS:
• spray liberally and spread evenly by hand 15 minutes before sun exposure.
• hold container 4 to 6 inches from the skin to apply
• do not spray directly into face. Spray on hands then apply to face.
• do not apply in windy conditions
• use in a well-ventilated area
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
•children under 6 months: Ask a doctor - KEEP OUT OF REACH OF CHILDREN
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WARNINGS:
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
For external use only.
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.
Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.
Stop use and ask a doctor if rash occurs.
Flammable: Do not use near heat, flame or while smoking. - Inactive Ingredients
- Other Information
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALOE UP DARK TANNING OIL SPF 4 CONTINUOUS SUNSCREEN
octinoxate, oxybenzone sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61477-216 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2 g in 100 mL Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CASTOR OIL (UNII: D5340Y2I9G) ALOE VERA LEAF (UNII: ZY81Z83H0X) COCONUT OIL (UNII: Q9L0O73W7L) MINERAL OIL (UNII: T5L8T28FGP) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) ALCOHOL (UNII: 3K9958V90M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61477-216-26 177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 02/24/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/24/2014 Labeler - Aloe Care International, LLC (938242187)
