CROC BLOC BROAD SPECTRUM SPF 30 FPS ECRAN SOLAIRE- homosalate, octisalate, octocrylene, oxybenzone, and avobenzone lotion

Croc Bloc Broad Spectrum SPF 30 FPS Ecran Solaire by

Drug Labeling and Warnings

Croc Bloc Broad Spectrum SPF 30 FPS Ecran Solaire by is a Otc medication manufactured, distributed, or labeled by Degil Safety Products (1989) Inc., CSR Cosmetic Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients		Purposes
Homosalate	10.5%	Sunscreen
Octisalate	5.0%	Sunscreen
Oxybenzone	2.0%	Sunscreen
Avobenzone	2.0%	Sunscreen
Octocrylene	2.0%	Sunscreen

Warnings

For external use only

• Discontinue use if skin irritation develops or increases
• If irritation persists, consult a health care practitioner

• Avoid contact with eyes
• If contact occurs, rinse thoroughly with water

• Consult a healthcare practitioner prior to use on children less than six months of age

• May stain or damage some fabrics or surfaces

• Keep out of reach of children

Directions

Shake well. Apply generously 15-30 minutes prior to exposure to the sun. Reapply as needed or after swimming, towel drying, perspiring heavily, washing and vigorous activity.

Other Ingredients

Aqua, Sorbitan Isostearate, Sorbitol, Triethanolamine, Polyglyceryl-3 Distearate, Stearic Acid, Octadecene/MA Copolymer, Barium Sulfate, Benzyl Alcohol, VP/Eicosene Copolymer, Dimethicone, Carbomer, Methyl-paraben, Aloe Barbadensis Leaf Extract, Simmondsia Chinesis (Jojoba) Seed Oil, Tocopherol, Propylparaben, Disodium EDTA

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label

Sunscreen

SPF 30 FPS

Écran Solaire

BROAD SPECTRUM LARGE SPECTRE
UVA/UVB PROTECTION

CONTRE LES RAYONS UVA ET UVB

Dermatologist Tested Moisturizing Aloe & Vitamin E

Unscented Lotion Water Sweat Resistant (40 Minutes)
Testé par les dermatologues Hydratante avec Vitamine E et Aloés

Lotion Non Parfumée Résiste à l'eau

INGREDIENTS AND APPEARANCE

CROC BLOC BROAD SPECTRUM SPF 30 FPS ECRAN SOLAIRE 
homosalate, octisalate, octocrylene, oxybenzone, and avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58331-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SORBITOL (UNII: 506T60A25R)
TROLAMINE (UNII: 9O3K93S3TK)
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
STEARIC ACID (UNII: 4ELV7Z65AP)
BARIUM SULFATE (UNII: 25BB7EKE2E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIMETHICONE (UNII: 92RU3N3Y1O)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
METHYLPARABEN (UNII: A2I8C7HI9T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58331-030-01	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/26/2020
2	NDC: 58331-030-02	10 mL in 1 PACKET; Type 0: Not a Combination Product	02/26/2020
3	NDC: 58331-030-03	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/26/2020
4	NDC: 58331-030-04	180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/26/2020
5	NDC: 58331-030-05	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/15/2013

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

Registrant - CSR Cosmetic Solutions (243501959)