CROC BLOC SPF 30 FPS ECRAN SOLAIRE- octinoxate, octisalate, oxybenzone, avobenzone, octocrylene liquid spray sunscreen liquid

CROC BLOC SPF 30 FPS ECRAN SOLAIRE by

Drug Labeling and Warnings

CROC BLOC SPF 30 FPS ECRAN SOLAIRE by is a Otc medication manufactured, distributed, or labeled by Degil Safety Products (1989) Inc., A.I.G. Technologies Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Octinoxate	7.5% w/w	Sunscreen
Octisalate	4.0% w/w	Sunscreen
Oxybenzone	4.0% w/w	Sunscreen
Avobenzone	2.0% w/w	Sunscreen
Octocylene	1.5% w/w	Sunscreen

Active Ingredients		Purposes
Octinoxate	7.5% w/w	Sunscreen
Octisalate	4.0% w/w	Sunscreen
Oxybenzone	4.0% w/w	Sunscreen
Avobenzone	2.0% w/w	Sunscreen
Octocylene	1.5% w/w	Sunscreen

Warnings

For external use only

May stain or damage some fabrics or surfaces.

DO NOT USE

on damaged or broken skin

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

WHEN USING

Avoid contact with eyes. Rinse with water to remove.

STOP USE

Rash and irritation develops and lasts

Directions

Apply liberally and evenly to dry skin 15 minutes belofe going Into the sun. Reapply at least fN8ry 2 houlS. Reapply after 80 minutes of swimming or sweating. Reapply lmmetlatety after towel drying.
For children under 6 months of age: Ask a doctor

Other Information

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 inciucling: limit time In the sun, especially from 10 a.m.-2 p.m.; and Wear long-sleeved shirts, pants, hats, and sunglasses. lf used as directed with
other sun protection measures (See Dlrections), decreases the risk of skin cancer and early skin aging caused by the sun. Protect container from freezing.

INACTIVE INGREDIENT

Aqua, Aloe Barbadensis Leaf Exlract, lsododecane, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Methyl Glucose Sesquistearate, PEG-20 Methyl Glucose Sesquistearate, Polyester-8. PVP/Hexadecene Copolymer, Tocopheryl Acetate, Decyl Glucoside. Stearyl Alcohol, Ceteareth-20, Microcrystalline Cellulose, Cellulose Gum, Propylene Glycol, Disodium EDTA, Triethanolamine, Diazolidinyl Urea, Methylparaben, Propylparaben.

PRINCIPAL DISPLAY PANEL

Liquid Spray

Sunscreen

SPF 30 FPS

Ecran solaire

en vaporisateur

liquide

BROAD SPECTRUM LARGE SPECTRE

UVA/UVB PROTECTION

CONTRE LES RAYONS UVA ET UVB

Hypoallergic Moisturizing Aloe & Vitamin E

Unscented Water Resistant (80 minutes)

Hypoallergenique Hydratante avec Vitamine E et Aloes

Non Parfumee Resiste a l'eau

INGREDIENTS AND APPEARANCE

CROC BLOC SPF 30 FPS ECRAN SOLAIRE 
octinoxate, octisalate, oxybenzone, avobenzone, octocrylene liquid spray sunscreen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58331-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58331-301-01	180 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/28/2020

Labeler - Degil Safety Products (1989) Inc. (247083686)

Establishment
Name	Address	ID/FEI	Business Operations
A.I.G. Technologies Inc.		171837367	manufacture(58331-301)