Label: HERBAL ALOE FACE AND BODY SPF 30- avobenzone. homosalate, octisalate, octocrylene, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51785-921-00, 51785-921-01 - Packager: Herbalife International of America Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 November 7, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
- Apply liberally 15 minutes before sun exposure
- Reapply:
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- Children under 6 months: Ask a doctor
- 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 the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients: Water (Aqua), Polyamide-8, Isoamyl Laurate, Butylene Glycol, Glycerin, Isodecyl Neopentanoate, Glyceryl Stearate, Aloe Barbadensis Leaf Juice, PEG-100 Stearate, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Yucca Filamentosa Extract, Artemisia Tridentata Extract, Simmondsia Chinensis (Jojoba) Seed Extract, Silybum Marianum Seed Extract, Salvia Hipanica Seed Extract, Agave Americana Leaf Extract, Physalis Angulata Extract, Polyacrylic Acid, Xylityl Sesquicaprylate, Euphorbia Cerifera (Candelilla) Wax, Diisopropyl Sebacate, Lauryl Lactate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance (Parfum), Triethanolamine, Sodium Hydroxide, Disodium EDTA, Sodium Benzoate, Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol, Phenoxyethanol.
- SPL UNCLASSIFIED SECTION
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SPL UNCLASSIFIED SECTION
HERBAL ALOE
FOR EVERY BODY, EVERY DAY
PROTECTS SKIN FROM SUN'S DAMAGING UVA/UVB RAYS
DOUBLES SKIN'S MOISTURE FOR 8 HOURS*
NO ADDED PARABENS•INCLUDES BOTANICALS
Protect your skin with this broad spectrum sunscreen that is sweat and water resistant up to 40 minutes. Contains aloe to hydrate skin, leaving it soft and smooth.
Pamper your skin and hair with our entire Herbal Aloe line:
- Strengthening Shampoo
- Strengthening Conditioner
- Hand & Body Wash
- Hand & Body Cream
- Soothing Aloe Gel
- Bath & Body Bar
The Skin Cancer Foundation recommends this product as an effective broad spectrum sunscreen.
*Tested on subjects, measuring skin moisture levels at eight hour intervals. Skin of 86% of subjects showed double the moisture levels over baseline after eight hours.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HERBAL ALOE FACE AND BODY SPF 30
avobenzone. homosalate, octisalate, octocrylene, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51785-921 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3.8844 g in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 6.24 g in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 6.06 g in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 3.4 g in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 7.2 g in 1 mL Inactive Ingredients Ingredient Name Strength POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) EDETATE DISODIUM (UNII: 7FLD91C86K) XYLITOL (UNII: VCQ006KQ1E) NEOPENTYL GLYCOL (UNII: QI80HXD6S5) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALOE VERA LEAF (UNII: ZY81Z83H0X) SODIUM BENZOATE (UNII: OJ245FE5EU) PHENOXYETHANOL (UNII: HIE492ZZ3T) YUCCA FILAMENTOSA (UNII: T6VR38UJ9I) ARTEMISIA TRIDENTATA TOP OIL (UNII: 84183U1G10) SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H) MILK THISTLE (UNII: U946SH95EE) CHIA SEED (UNII: NU0OLX06F8) AGAVE AMERICANA LEAF (UNII: 8511ZMP5QK) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) LAURYL LACTATE (UNII: G5SU0BFK7O) PHYSALIS ANGULATA (UNII: W4TKW9D5GG) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ISOAMYL LAURATE (UNII: M1SLX00M3M) SUNFLOWER OIL (UNII: 3W1JG795YI) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) CANDELILLA WAX (UNII: WL0328HX19) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51785-921-00 120 mL in 1 TUBE; Type 0: Not a Combination Product 08/25/2014 2 NDC:51785-921-01 1 in 1 CARTON 08/25/2014 2 120 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/25/2014 Labeler - Herbalife International of America Inc. (873035968)
