Label: ALOE UP BROAD SPECTRUM SPF 50 SUNSCREEN- homosalate, octisalate, avobenzone, octocrylene spray
- NDC Code(s): 13630-0181-4
- Packager: Prime Packaging Inc.
- Category: HUMAN OTC DRUG LABEL
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 October 27, 2021
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- Official Label (Printer Friendly)
- INACTIVE INGREDIENTS
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Warnings
For external use only
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.
- Purpose
- Uses
- Active Ingredients
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Directions
- Spray liberally and spread evenly 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 well-ventilated area
- Reapply:
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours.
- 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 of 15 or higher and other sun protecion measures including:
- Limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
- Other Information
- Questions or Comments?
- ALOE UP SPORT PERFORMANCE SUNSCREEN Broad spectrum SPF 50 - 5.5 oz (156 g)
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INGREDIENTS AND APPEARANCE
ALOE UP BROAD SPECTRUM SPF 50 SUNSCREEN
homosalate, octisalate, avobenzone, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0181 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 27.5 mg in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 g HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 150 mg in 1 g Inactive Ingredients Ingredient Name Strength DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) MINERAL OIL (UNII: T5L8T28FGP) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) ALCOHOL (UNII: 3K9958V90M) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) Product Characteristics Color yellow (Light Yellow) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0181-4 156 g in 1 CANISTER; Type 0: Not a Combination Product 08/28/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/28/2016 Labeler - Prime Packaging Inc. (805987059) Registrant - Prime Packaging Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises Inc. 101946028 manufacture(13630-0181) , label(13630-0181) , pack(13630-0181) , analysis(13630-0181) Establishment Name Address ID/FEI Business Operations Prime Packaging Inc. 805987059 pack(13630-0181) , label(13630-0181)
