Label: ALOE SUNSCREEN- homosalate, octisalate, avobenzone, ensulizole and octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 11697-199-05 - 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.
Drug Label Information
Updated January 21, 2015
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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INSTRUCTIONS FOR USE
Directions
- apply liberally 15 minutes before sun exposure
- rapply:
- 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 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
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INACTIVE INGREDIENT
Inactive ingredients
aloe barbadensis leaf juice (stabilized* aloe vera gel), butyloctyl salicylate, caprylic/capric triglyceride, cetearyl olivate, ceteth-20, cetyl alcohol, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, fragrance (parfum), glycerin, glyceryl stearate, hexyl laurate, methylisothiazolinone, PEG-75 stearate, phenoxyethanol, polyglyceryl-4 isostearate, sodium chloride, sorbitan olivate, steareth-20, tocopheryl acetate, triethanolamine, water (aqua), xanthan gum - INDICATIONS & USAGE
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALOE SUNSCREEN
homosalate, octisalate, avobenzone, ensulizole and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11697-199 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 AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g in 100 mL ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 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) 29.4 g in 100 mL WATER (UNII: 059QF0KO0R) 29.2 g in 100 mL BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) 3.0 g in 100 mL MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 3.0 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 2.0 g in 100 mL CETEARYL OLIVATE (UNII: 58B69Q84JO) 1.7 g in 100 mL SORBITAN OLIVATE (UNII: MDL271E3GR) 1.4 g in 100 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) 1.0 g in 100 mL CETYL ALCOHOL (UNII: 936JST6JCN) 0.7 g in 100 mL GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 0.7 g in 100 mL POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) 0.7 g in 100 mL HEXYL LAURATE (UNII: 4CG9F9W01Q) 0.7 g in 100 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.3 g in 100 mL PEG-75 STEARATE (UNII: OT38R0N74H) 0.3 g in 100 mL TRIETHYLAMINE (UNII: VOU728O6AY) 0.3 g in 100 mL XANTHAN GUM (UNII: TTV12P4NEE) 0.2 g in 100 mL CETETH-20 (UNII: I835H2IHHX) 0.2 g in 100 mL STEARETH-20 (UNII: L0Q8IK9E08) 0.1 g in 100 mL ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.1 g in 100 mL METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) 0.01 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11697-199-05 118.000 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/06/2011 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(11697-199)
