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

----------

Croc Bloc Broad Spectrum SPF 30 FPS Ecran Solaire

Drug Facts

Active IngredientsPurposes
Homosalate10.5%Sunscreen
Octisalate5.0%Sunscreen
Oxybenzone2.0%Sunscreen
Avobenzone2.0%Sunscreen
Octocrylene2.0%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

Outer label

CROC BLOC BROAD SPECTRUM SPF 30 FPS ECRAN SOLAIRE 
homosalate, octisalate, octocrylene, oxybenzone, and avobenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58331-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58331-030-01120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/21/2022
2NDC:58331-030-0210 mL in 1 PACKET; Type 0: Not a Combination Product11/21/2022
3NDC:58331-030-0330 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/21/2022
4NDC:58331-030-04180 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/21/2022
5NDC:58331-030-051000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/21/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/15/2013
Labeler - Degil Safety Products (1989) Inc. (247083686)
Registrant - CSR Cosmetic Solutions (243501959)

Revised: 11/2022
Document Id: ee02700b-98ed-9de2-e053-2995a90adc04
Set id: deef029f-2fbf-4ae7-b261-01d5d4a0f6c1
Version: 5
Effective Time: 20221121
 
Degil Safety Products (1989) Inc.