Label: ALOE SUNSCREEN- homosalate, octisalate, avobenzone, ensulizole anf octocrylene spray
- NDC Code(s): 11697-319-07
- Packager: Aloe Vera of America, 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.
Updated January 22, 2015
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- ACTIVE INGREDIENT
Active Ingredients Purpose
Octocrylene 2.79% SunscreenClose
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
For external use onlyClose
- DO NOT USE
Do not use on damaged or broken skinClose
- WHEN USING
When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing product.Close
- STOP USE
Stop use and ask doctor if rash occursClose
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.Close
- INSTRUCTIONS FOR USE
Shake well before use.
- hold container 4 to 6 inches from the skin and spray generously and spread evenly by hand 15 minutes before sun exposure
- do not spray directly into face. Spray on hands then apply to face.
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- do not apply in windy conditions
- use in well-ventilated 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 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 INGREDIENT
acrylates/C12-22 alkyl methacrylate copolymer, acrylates copolymer, aloe barbadensis leaf juice (stabilized* aloe vera gel), butyloctyl salicylate, ceteareth-25, diethylhexyl carbonate, disodium ethylene dicocamide PEG-15 disulfate, disodium EDTA, fragrance (parfum), methylisothiazolinone, neopentyl glycol diheptanoate, panthenol, pentylene glycol, phenoxyethanol, polyester-7, propanediol, styrene/acrylates copolymer, tocopheryl acetate, triethanolamine, water (aqua)
- INDICATIONS & USAGE
- protect this product from excessive heat and direct sun
Questions: Call 1-888-440-2563, Monday - Friday, 9:00 a.m. to 4:00 p.m. PT.Close
- INGREDIENTS AND APPEARANCE
homosalate, octisalate, avobenzone, ensulizole anf octocrylene spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11697-319 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10.0 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5.0 g in 100 mL ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 4.0 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.0 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.79 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) 29.3 g in 100 mL WATER (UNII: 059QF0KO0R) 27.3 g in 100 mL PROPANEDIOL (UNII: 5965N8W85T) 3.0 g in 100 mL DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L) 3.0 g in 100 mL BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 3.0 g in 100 mL POLYESTER-7 (UNII: 0841698D2F) 2.4 g in 100 mL STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) 1.9 g in 100 mL NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) 1.6 g in 100 mL CETEARETH-25 (UNII: 8FA93U5T67) 0.7 g in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.3 g in 100 mL DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W) 0.3 g in 100 mL PENTYLENE GLYCOL (UNII: 50C1307PZG) 0.1 g in 100 mL PANTHENOL (UNII: WV9CM0O67Z) 0.1 g in 100 mL .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.01 g in 100 mL METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 0.01 g in 100 mL EDETATE DISODIUM (UNII: 7FLD91C86K) 0.1 g in 100 mL TROLAMINE (UNII: 9O3K93S3TK) 0.3 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11697-319-07 178.000 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/16/2010 Labeler - Aloe Vera of America, Inc. (049049463) Registrant - Aloe Vera of America, Inc. (049049463) Establishment Name Address ID/FEI Business Operations Aloe Vera of America, Inc. 049049463 manufacture(11697-319)