CROC BLOC SPF 30 FPS ECRAN SOLAIRE- octinoxate, octisalate, oxybenzone, avobenzone, octocrylene liquid spray sunscreen liquid 
Degil Safety Products (1989) Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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.

on damaged or broken skin

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

Avoid contact with eyes. Rinse with water to remove.

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.

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

Principal panel

CROC BLOC SPF 30 FPS ECRAN SOLAIRE 
octinoxate, octisalate, oxybenzone, avobenzone, octocrylene liquid spray sunscreen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58331-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58331-301-01180 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/28/2020
Labeler - Degil Safety Products (1989) Inc. (247083686)
Establishment
NameAddressID/FEIBusiness Operations
A.I.G. Technologies Inc.171837367manufacture(58331-301)

Revised: 5/2020
Document Id: a691b9b1-166f-efbf-e053-2995a90aabf3
Set id: a691b9b1-166e-efbf-e053-2995a90aabf3
Version: 1
Effective Time: 20200526
 
Degil Safety Products (1989) Inc.