Label: ALOE SOOTHING MOISTURE SPF 15- octisalate, avobenzone, octinoxate, and octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 57691-889-50 - Packager: Buth-Na-Bodhaige, 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 10, 2016
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure.
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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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in sun especially from 10 a.m. – 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses.
- reapply this product at least every 2 hours.
- use a water resistant sunscreen if swimming or sweating.
- children under 6 months of age: ask a doctor.
- Other information
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Inactive Ingredients
Water, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, Butylene Glycol, Caprylic/Capric Triglyceride, Sorbitol, Cetearyl Alcohol, Potassium Cetyl Phosphate, Sesamum Indicum (Sesame) Seed Oil, Dimethicone, Phenoxyethanol, Caprylyl Glycol, Panthenol, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice Powder, Xanthan Gum, Carbomer, Bisabolol, Potassium Sorbate, Tetrasodium EDTA, Sodium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Pentylene Glycol, BHT, Avena Sativa (Oat) Kernel Extract, Citric Acid.
- PRINCIPAL DISPLAY PANEL - 50 ml Tube Label
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INGREDIENTS AND APPEARANCE
ALOE SOOTHING MOISTURE SPF 15
octisalate, avobenzone, octinoxate, and octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57691-889 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 0.05 g in 1 mL Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 0.03 g in 1 mL Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.029 g in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 0.022 g in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Glycerin (UNII: PDC6A3C0OX) Butylene Glycol (UNII: 3XUS85K0RA) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Sorbitol (UNII: 506T60A25R) Cetostearyl Alcohol (UNII: 2DMT128M1S) Potassium Cetyl Phosphate (UNII: 03KCY6P7UT) SESAME OIL (UNII: QX10HYY4QV) Dimethicone (UNII: 92RU3N3Y1O) Phenoxyethanol (UNII: HIE492ZZ3T) Caprylyl Glycol (UNII: 00YIU5438U) Panthenol (UNII: WV9CM0O67Z) SHEA BUTTER (UNII: K49155WL9Y) ALOE VERA LEAF (UNII: ZY81Z83H0X) Xanthan Gum (UNII: TTV12P4NEE) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) LEVOMENOL (UNII: 24WE03BX2T) Potassium Sorbate (UNII: 1VPU26JZZ4) EDETATE SODIUM (UNII: MP1J8420LU) Sodium Hydroxide (UNII: 55X04QC32I) Pentylene Glycol (UNII: 50C1307PZG) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) OAT (UNII: Z6J799EAJK) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57691-889-50 50 mL in 1 TUBE; Type 0: Not a Combination Product 04/11/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 04/11/2016 Labeler - Buth-Na-Bodhaige, Inc., (791071279)
