VITAMIN E MOISTURE-PROTECT SPF 30 PA PLUS PLUS PLUS- octisalate, homosalate, avobenzone, octocrylene, and octinoxate lotion

VITAMIN E MOISTURE-PROTECT SPF 30 PA plus plus plus by

Drug Labeling and Warnings

VITAMIN E MOISTURE-PROTECT SPF 30 PA plus plus plus by is a Otc medication manufactured, distributed, or labeled by Buth-Na-Bodhaige, Inc.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Avobenzone (3.0% w/w)	Sunscreen
Homosalate (8.0% w/w)	Sunscreen
Octinoxate (2.0% w/w)	Sunscreen
Octisalate (4.0% w/w)	Sunscreen
Octocrylene (7.0% w/w)	Sunscreen

Uses

• helps prevent sunburn.

Warnings

For external use only

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

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

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply at least every 2 hours
• Use a water resistant sunscreen if swimming or sweating
• 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 sun especially from 10 a.m.– 2 p.m.
  • wear long sleeved shirts, pants, hats and sunglasses.
• children under 6 months of age: ask a doctor.

Other information

• protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Water, Glycerin, Butylene Glycol, Dimethicone, Cetearyl Alcohol, Glyceryl Stearate, Magnesium Silicate, PEG-100 Stearate, Polymethylsilsesquioxane, Coco-Caprylate/Caprate, Phenoxyethanol, Polysorbate 60, Tocopheryl Acetate, Caprylyl Glycol, Triticum Vulgare (Wheat) Germ Oil, Polysilicone-11, Xanthan Gum, Fragrance, Aloe Barbadensis Leaf Juice Powder, Sodium Hyaluronate, Benzyl Benzoate, Potassium Sorbate, Disodium EDTA, Benzyl Alcohol, Hydroxycitronellal, Limonene, Geraniol, Linalool, Sodium Hydroxide, Citric Acid, Citronellol, Cinnamyl Alcohol, Decyl Glucoside, Alpha-Isomethyl Ionone, BHT, Isoeugenol, Hexylene Glycol.

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

THE
BODY
SHOP®

THE BODY SHOP
VITAMIN E

MOISTURE-PROTECT
EMULSION

BROAD SPECTRUM
SPF 30 SUNSCREEN

WITH VITAMIN E & WHEATGERM OIL, & WITH
BIOFERMENTED HYALURONIC ACID
FROM POMACLE, FRANCE

50 ml (1.69 US FL OZ)

ALL SKIN TYPES

INGREDIENTS AND APPEARANCE

VITAMIN E MOISTURE-PROTECT SPF 30 PA PLUS PLUS PLUS 
octisalate, homosalate, avobenzone, octocrylene, and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57691-970
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.04 g  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	0.08 g  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.03 g  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.07 g  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Butylene Glycol (UNII: 3XUS85K0RA)
Dimethicone (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Magnesium Silicate (UNII: 9B9691B2N9)
PEG-100 Stearate (UNII: YD01N1999R)
Polymethylsilsesquioxane (4.5 Microns) (UNII: 59Z907ZB69)
Coco-Caprylate/Caprate (UNII: 8D9H4QU99H)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polysorbate 60 (UNII: CAL22UVI4M)
Caprylyl Glycol (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Wheat Germ Oil (UNII: 14C97E680P)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
Xanthan Gum (UNII: TTV12P4NEE)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Benzyl Benzoate (UNII: N863NB338G)
Potassium Sorbate (UNII: 1VPU26JZZ4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Hydroxycitronellal (UNII: 8SQ0VA4YUR)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
Geraniol (UNII: L837108USY)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
Sodium Hydroxide (UNII: 55X04QC32I)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
Cinnamyl Alcohol (UNII: SS8YOP444F)
Decyl Glucoside (UNII: Z17H97EA6Y)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Hexylene Glycol (UNII: KEH0A3F75J)
BENZYL ALCOHOL (UNII: LKG8494WBH)
Isoeugenol (UNII: 5M0MWY797U)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57691-970-50	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/15/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/15/2018

Labeler - Buth-Na-Bodhaige, Inc., (791071279)