Label: CROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE- homosalate, octisalate, octocrylene, oxybenzone, and avobenzone lotion
- NDC Code(s): 58331-050-01, 58331-050-02, 58331-050-03
- Packager: Degil Safety Products (1989) Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 21, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- DO NOT USE
- Keep out of reach of children
- When using this product
- Stop use and ask doctor if
- Directions
- Other Information
- Inactive Ingredients
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PRINCIPAL DISPLAY PANEL
UVA / UVB PROTECTION
CONTRE LES RAYONS UVA ET UVB
Dermatologist Tested • Gentle Lotion formula
Unscented • Water Resistant (80 Minutes)
Testé par les dermatologues • Formule écran solaire
Douce • Non Parfumée • Résistant à I'eau
Sunscreen
SPF 50 FPS
Écran Solaire
Distributed by/Distribué par:
Croc Bloc Products Inc.
200 Zenway Blvd., Unit 1 Vaughan, Ontario, Canada
1-800-332-1810
Email: degil@degilsafety.com
Website: www.degilsafety.com
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INGREDIENTS AND APPEARANCE
CROC BLOC BROAD SPECTRUM SPF 50 FPS ECRAN SOLAIRE
homosalate, octisalate, octocrylene, oxybenzone, and avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58331-050 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 4 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 13 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) DIMETHICONE (UNII: 92RU3N3Y1O) TOCOPHEROL (UNII: R0ZB2556P8) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) EDETATE DISODIUM (UNII: 7FLD91C86K) TROLAMINE (UNII: 9O3K93S3TK) SORBITOL (UNII: 506T60A25R) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) WATER (UNII: 059QF0KO0R) STEARIC ACID (UNII: 4ELV7Z65AP) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58331-050-01 120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/21/2022 2 NDC:58331-050-03 750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/21/2022 3 NDC:58331-050-02 10 mL in 1 PACKET; Type 0: Not a Combination Product 11/21/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/18/2020 Labeler - Degil Safety Products (1989) Inc. (247083686)