Label: HERBALIFE SKIN PROTECTIVE MOISTURIZER SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51785-899-02 - 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 December 18, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- PURPOSE
- ACTIVE INGREDIENT
- 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
• Use a water resistant sunscreen if swimming or sweating
• Reapply 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), Butylene Glycol, Dimethicone, Glyceryl Stearate, Carthamus Tinctorius (Safflower) Oleosomes, Potassium Cetyl Phosphate, PEG-100 Stearate, Glycerin, Isoamyl Laurate, Isodecyl Neopentanoate, Niacinamide, Ascorbyl Glucoside, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Physalis Angulata Extract, Caprylic/Capric Triglyceride, Diisopropyl Sebacate, Lauryl Lactate, Dimethicone Crosspolymer, Carbomer, Xanthan Gum, Fragrance (Parfum), Triethanolamine, Sodium Citrate, Citric Acid, Disodium EDTA, Sodium Benzoate, Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol, Phenoxyethanol.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HERBALIFE SKIN PROTECTIVE MOISTURIZER SPF 30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51785-899 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.8505 g in 30 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.9711 g in 30 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 1.56 g in 30 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.515 g in 30 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 1.8 g in 30 mL Inactive Ingredients Ingredient Name Strength NIACINAMIDE (UNII: 25X51I8RD4) PHYSALIS ANGULATA (UNII: W4TKW9D5GG) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ALOE VERA LEAF (UNII: ZY81Z83H0X) ISOAMYL LAURATE (UNII: M1SLX00M3M) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) PHENOXYETHANOL (UNII: HIE492ZZ3T) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309) SODIUM CITRATE (UNII: 1Q73Q2JULR) EDETATE DISODIUM (UNII: 7FLD91C86K) XANTHAN GUM (UNII: TTV12P4NEE) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERIN (UNII: PDC6A3C0OX) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) LAURYL LACTATE (UNII: G5SU0BFK7O) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TROLAMINE (UNII: 9O3K93S3TK) SODIUM BENZOATE (UNII: OJ245FE5EU) DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51785-899-02 1 in 1 CARTON 07/01/2014 1 30 mL in 1 BOTTLE, PUMP; 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 07/01/2014 Labeler - Herbalife International of America Inc. (873035968)
