Label: HERBALIFE SKIN PROTECTIVE MOISTURIZER BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN- zinc oxide cream
- NDC Code(s): 51785-900-00
- 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 July 20, 2022
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
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
• Apply liberally 15 minutes before sun
exposure
• Reapply at least every 2 hours
• Use a water resistant sunscreen if
swimming or sweating
• 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
-
INACTIVE INGREDIENT
Inactive ingredients:
Water (Aqua), Caprylic/Capric
Triglyceride, Glycerin, Cetearyl Alcohol,
Coco-Glucoside, Silica, Aloe Barbadensis
Leaf Juice, Niacinamide, Tetrahexyldecyl
Ascorbate, Tocopheryl Acetate, Physalis
Angulata Extract, Cocoyl Proline,
Lecithin, Isostearic Acid, Polyglyceryl-3
Polyricinoleate, Polyhydroxystearic Acid,
Xanthan Gum, Fragrance (Parfum),
Disodium EDTA, Ethylhexylglycerin,
Hexylene Glycol, Caprylyl Glycol,
Phenoxyethanol. - SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HERBALIFE SKIN PROTECTIVE MOISTURIZER BROAD SPECTRUM SPF 30 MINERAL SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51785-900 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 17.5 g in 100 mL Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) CAPRYLYL GLYCOL (UNII: 00YIU5438U) COCO GLUCOSIDE (UNII: ICS790225B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HEXYLENE GLYCOL (UNII: KEH0A3F75J) ISOSTEARIC ACID (UNII: X33R8U0062) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHYSALIS ANGULATA (UNII: W4TKW9D5GG) NIACINAMIDE (UNII: 25X51I8RD4) ALOE VERA LEAF (UNII: ZY81Z83H0X) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) COCOYL PROLINE (UNII: 0IH06971TF) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51785-900-00 1 in 1 CARTON 05/01/2022 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 05/01/2022 Labeler - Herbalife International of America Inc. (873035968)
