Label: HERBALIFE HERBAL ALOE FACE AND BODY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide cream
- NDC Code(s): 51785-922-00
- 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:
• 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
-
INACTIVE INGREDIENT
Inactive ingredients:
Water (Aqua), Caprylic/Capric Triglyceride, Butyloctyl
Salicylate, Dimethicone, Glycerin, Cetearyl Olivate, Sorbitan
Olivate, VP/Eicosene Copolymer, Aloe Barbadensis Leaf Juice,
Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate,
Triethoxycaprylylsilane, Cetearyl Alcohol, Polyhydroxystearic
Acid, Xanthan Gum, Fragrance (Parfum), Disodium EDTA,
Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol,
Phenoxyethanol. - SPL UNCLASSIFIED SECTION
-
SPL UNCLASSIFIED SECTION
HERBAL ALOE
FOR EVERY BODY, EVERY DAY
PROTECTS SKIN FROM SUN’S
DAMAGING UVA/UVB RAYS
NO ADDED PARABENS • INCLUDES BOTANICALS
Protect your skin with this broad spectrum sunscreen that is
sweat and water resistant (40 minutes). Formulated with aloe to
hydrate the skin, leaving it feeling 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. - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HERBALIFE HERBAL ALOE FACE AND BODY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51785-922 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 19.24 g in 100 mL Inactive Ingredients Ingredient Name Strength SORBITAN OLIVATE (UNII: MDL271E3GR) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) SHEA BUTTER (UNII: K49155WL9Y) XANTHAN GUM (UNII: TTV12P4NEE) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CAPRYLYL GLYCOL (UNII: 00YIU5438U) WATER (UNII: 059QF0KO0R) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ALOE VERA LEAF (UNII: ZY81Z83H0X) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) DIMETHICONE 350 (UNII: 2Y53S6ATLU) CETEARYL OLIVATE (UNII: 58B69Q84JO) PHENOXYETHANOL (UNII: HIE492ZZ3T) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) HEXYLENE GLYCOL (UNII: KEH0A3F75J) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51785-922-00 1 in 1 CARTON 05/01/2022 1 120 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 05/01/2022 Labeler - Herbalife International of America, Inc. (873035968)
