Label: VERTRA MICK FANNING SIGNATURE FOUNDATION SUNSCREEN FACE STICK SPF 35 COOLANGATTA BEIGE- titanium dioxide stick
- NDC Code(s): 66990-1025-1
- Packager: Toshiki Pigment Co., Ltd.
- 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 May 25, 2023
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- ACTIVE INGREDIENT
-
PURPOSE
- 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.
- Higher SPF gives more sunburn protection.
- Retains SPF after 80 minutes activity in the water, sweating or perspiring.
- Provides high protection against sunburn.
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
- Apply liberally and generously 15 minutes before sun exposure and at least every 2 hours.
- Children under 6 months of age: 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 your time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
- Reapply:
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VERTRA MICK FANNING SIGNATURE FOUNDATION SUNSCREEN FACE STICK SPF 35 COOLANGATTA BEIGE
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66990-1025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 23 g in 100 g Inactive Ingredients Ingredient Name Strength MICA (UNII: V8A1AW0880) FERROSOFERRIC OXIDE (UNII: XM0M87F357) STEARIC ACID (UNII: 4ELV7Z65AP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HEXYLDECYL ISOSTEARATE (UNII: 3V20TC06U5) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CERESIN (UNII: Q1LS2UJO3A) TOCOPHEROL (UNII: R0ZB2556P8) STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P) PARAFFIN (UNII: I9O0E3H2ZE) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66990-1025-1 11 g in 1 CARTON; Type 0: Not a Combination Product 01/27/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 01/27/2021 Labeler - Toshiki Pigment Co., Ltd. (716140285) Establishment Name Address ID/FEI Business Operations Toshiki Pigment Co., Ltd. 716140285 manufacture(66990-1025)
