HERBAL ALOE FACE AND BODY SPF 30- avobenzone. homosalate, octisalate, octocrylene, oxybenzone cream

Herbal Aloe Face and Body SPF 30 by

Drug Labeling and Warnings

Herbal Aloe Face and Body SPF 30 by is a Otc medication manufactured, distributed, or labeled by Herbalife International of America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients

Avobenzone (3%)

Homosalate (5%)

Octisalate (5%)

Octocrylene (2.7%)

Oxybenzone (5%)

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use on damaged or broken skin

STOP USE

Stop use and ask a doctor if rash occurs

WHEN USING

When using this product keep out of eyes. Rinse with water to remove.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Other information

• Protect this product in the container from excessive heat and direct sunlight

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

Distributed by

Herbalife International of America, Inc.

800 W. Olymic Blvd., Suite 406

Los Angeles, CA 90015, USA

Made in USA with US and imported ingredients.

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 PARABENSINCLUDES 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

HERBALIFE

HERBAL ALOE

FACE & BODY SUNSCREEN

BROAD SPECTRUM SPF 30

SWEAT & WATER RESISTANT

(40 MINUTES)

4 fl oz (120 ml)

INGREDIENTS AND APPEARANCE

HERBAL ALOE FACE AND BODY SPF 30 
avobenzone. homosalate, octisalate, octocrylene, oxybenzone cream

Product 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)