Label: ALOE UP BROAD SPECTRUM SPF 15- avobenzone, octisalate, and octocrylene spray
- NDC Code(s): 13630-0205-4
- 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 January 18, 2022
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- Official Label (Printer Friendly)
- Active ingredients
- PURPOSE
- Uses
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Warnings
For external use only
When using this product keep out of eyes. Rinse with water to remove. Keep away rom face to avoid breathing it. Contents under pressre - do not puncture or incinerate. Do not store at temperatures above 120º F.
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Directions
- Spray liberally and spread 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 well ventilated area
- Reapply:
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hour
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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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
- Inactive Ingredients
- Other information
- QUESTIONS
- Aloe Up Sport Broad Spectrum SPF 15 Continuous Spray
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INGREDIENTS AND APPEARANCE
ALOE UP BROAD SPECTRUM SPF 15
avobenzone, octisalate, and octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0205 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 16.24 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 40.6 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 15.02 mg in 1 mL Inactive Ingredients Ingredient Name Strength DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) MINERAL OIL (UNII: T5L8T28FGP) COCONUT OIL (UNII: Q9L0O73W7L) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) ALCOHOL (UNII: 3K9958V90M) 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:13630-0205-4 192 mL in 1 CAN; Type 0: Not a Combination Product 09/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/30/2021 Labeler - Prime Packaging, Inc. (805987059) Registrant - Prime Packaging, Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 analysis(13630-0205) , manufacture(13630-0205) Establishment Name Address ID/FEI Business Operations Prime Packaging, Inc. 805987059 pack(13630-0205) , label(13630-0205)
