Label: CLEARSPF TINTED SUNSCREEN- zinc oxide lotion
- NDC Code(s): 69949-251-01
- Packager: Synchronicity Spa, Inc. DBA Suntegrity
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 June 22, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
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Uses
Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Children under 6 months: Ask a doctor.
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 including: Limit time in the sun, especially from 10a.m.– 2p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses.
- Other information
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Inactive Ingredients
Water, Butyloctyl Salicylate, Coco-Caprylate, Niacinamide, Caprylic/Capric Triglyceride, Polyhydroxystearic Acid, Glycerin, Panthenol, Tocopheryl Acetate, Sucrose Palmitate, Glyceryl, Stearate, Xanthan Gum, Citric Acid, Saccharide, Isomerate, Sucrose Tristearate, Sodium Stearoyl Glutamate, Benzyl Alcohol, Octyldodecanol, Jojoba Esters, Dehydroacetic Acid, Trihydroxystearin, Sodium Phytate, Iron Oxides (CI 77491)(CI 77492)(CI 77499)
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 48 g Bottle Label
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INGREDIENTS AND APPEARANCE
CLEARSPF TINTED SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69949-251 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) COCO-CAPRYLATE (UNII: 4828G836N6) NIACINAMIDE (UNII: 25X51I8RD4) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) GLYCERIN (UNII: PDC6A3C0OX) PANTHENOL (UNII: WV9CM0O67Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SUCROSE PALMITATE (UNII: 3OSQ643ZK5) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) XANTHAN GUM (UNII: TTV12P4NEE) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SACCHARIDE ISOMERATE (UNII: W8K377W98I) SUCROSE TRISTEARATE (UNII: 71I93STU5M) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) BENZYL ALCOHOL (UNII: LKG8494WBH) OCTYLDODECANOL (UNII: 461N1O614Y) JOJOBA OIL (UNII: 724GKU717M) DEHYDROACETIC ACID (UNII: 2KAG279R6R) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) PHYTATE SODIUM (UNII: 88496G1ERL) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69949-251-01 48 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/01/2023 Labeler - Synchronicity Spa, Inc. DBA Suntegrity (079164130)
