VITAMIN C GLOW-PROTECT SPF 30- octisalate, avobenzone, octinoxate, and octocrylene lotion

VITAMIN C GLOW-PROTECT SPF 30 by

Drug Labeling and Warnings

VITAMIN C GLOW-PROTECT SPF 30 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 (2.0% w/w)	Sunscreen
Octinoxate (7.5% w/w)	Sunscreen
Octisalate (5.0% w/w)	Sunscreen
Octocrylene (5.0% 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 of 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.
• 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.
• reapply this product at least every 2 hours.
• use water resistant sunscreen if swimming or sweating.
• 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, Isododecane, Hydrogenated Polydecene, Glycerin, Glyceryl Stearate, Arachidyl Alcohol, Caprylyl Glycol, Behenyl Alcohol, PEG-100 Stearate, Arachidyl Glucoside, Cetyl Alcohol, Sesamum Indicum (Sesame) Seed Oil, Tetrahexyldecyl Ascorbate, Phenoxyethanol, Acrylamide/Ammonium Acrylate Copolymer, Fragrance, Xanthan Gum, Polyisobutene, Dimethicone, Myrciaria Dubia Fruit Extract, Sorbic Acid, Disodium EDTA, Linalool, Limonene, Polysorbate 20, Sorbitan Isostearate, Benzyl Benzoate, Citral, Potassium Sorbate, Hexyl Cinnamal, Citronellol.

PRINCIPAL DISPLAY PANEL - 50 ml Tube Label

THE
BODY
SHOP®

THE BODY SHOP
VITAMIN C

GLOW-PROTECT LOTION
BROADSPECTRUM SUNSCREEN SPF 30

WITH VITAMIN C RICH CAMU CAMU
FROM THE AMAZONIAN
RAINFOREST, PERU

50 ml (1.69 US FL OZ)

DULL, TIRED, GRUMPY SKIN

INGREDIENTS AND APPEARANCE

VITAMIN C GLOW-PROTECT SPF 30 
octisalate, avobenzone, octinoxate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57691-977
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	0.05 g  in 1 mL
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	0.02 g  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Isododecane (UNII: A8289P68Y2)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
Glycerin (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Caprylyl Glycol (UNII: 00YIU5438U)
DOCOSANOL (UNII: 9G1OE216XY)
PEG-100 Stearate (UNII: YD01N1999R)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Cetyl Alcohol (UNII: 936JST6JCN)
SESAME OIL (UNII: QX10HYY4QV)
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)
Phenoxyethanol (UNII: HIE492ZZ3T)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
Xanthan Gum (UNII: TTV12P4NEE)
POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K)
Dimethicone (UNII: 92RU3N3Y1O)
MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP)
Sorbic Acid (UNII: X045WJ989B)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Polysorbate 20 (UNII: 7T1F30V5YH)
Sorbitan Isostearate (UNII: 01S2G2C1E4)
Potassium Sorbate (UNII: 1VPU26JZZ4)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57691-977-50	50 mL in 1 TUBE; Type 0: Not a Combination Product	05/14/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	05/14/2016

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