GUARD SUNSCREEN BROAD SPECTRUM SPF 30- octinoxate, avobenzone lotion

Guard Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Guard Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by COSMETIC ENTERPRISES LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Ethylhexylmethoxycinnamate (Octinoxate) 2.0% Sunscreen

ButylMethoxydibenzoylmethane (avobenzone) .5% Sunscreen

PURPOSE

Uses

Helps Prevent Sunburn

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

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.

DOSAGE & ADMINISTRATION

Directions

For Sunscreen use:

• Aply 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 the 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

INACTIVE INGREDIENT

Inactive ingredients: Water, Carthamus Tinctorius (Safflower) Oleosomes, C12-15 Alkyl Benzoate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Phospholipids, Retinyl Palmitate (Vitamin A), Ascorbyl Palmitate (Vitamin C), Tocopheryl Nicotinate, Beta Glucan, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Disodium EDTA, Vanilla Planifola Fruit Extract

PRINCIPAL DISPLAY PANEL

Guard Sunscreen

High Definition Protection

Ecran Solaire Total

Haute Definition

SPF 30

Broad Spectrum UVA/UVB

Anti-age

1.5fl oz/ 44ml

INGREDIENTS AND APPEARANCE

GUARD SUNSCREEN BROAD SPECTRUM SPF 30 
octinoxate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56152-5008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)
VANILLA (UNII: Q74T35078H)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56152-5008-1	44 mL in 1 CARTON; Type 0: Not a Combination Product	12/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/20/2018

Labeler - COSMETIC ENTERPRISES LTD (017701475)

Registrant - COSMETIC ENTERPRISES LTD (017701475)

Establishment
Name	Address	ID/FEI	Business Operations
COSMETIC ENTERPRISES LTD		017701475	manufacture(56152-5008)