Label: 2000DL-CL30V- spf30 bs original lotion
- NDC Code(s): 58418-000-06
- Packager: Tropical Enterprises International, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 14, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
WARNINGS: Skin Cancer/ Sking Aging Alert: Spending time in the sun
increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer and early skin aging.
For external use only.
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if irritation or rash occurs.
- Keep out of reach of children.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
2000DL-CL30V
spf30 bs original lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58418-000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 2.34 g in 30 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.9 g in 30 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) WATER (UNII: 059QF0KO0R) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) SORBETH-12 HEXAOLEATE (UNII: F3ECF77W74) BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Product Characteristics Color white (white to off-white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58418-000-06 177 mL in 1 TUBE; Type 0: Not a Combination Product 10/02/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/01/2023 Labeler - Tropical Enterprises International, Inc. (091986179)