Label: VERTRA S DORIAN KONA GOLD SIGNATURE FACE STICK SPF 38- titanium dioxide stick
- NDC Code(s): 66990-1021-1
- 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 31, 2023
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- ACTIVE INGREDIENT
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PURPOSE
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
- 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
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DOSAGE & ADMINISTRATION
Directions
Apply liberally and generously 15 minutes before sun exposure and at least every 2 hours and at least every 2 hours.
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
•Children under 6 months of age: ask a doctor
Reapply:
After 80 minutes of swimming or sweating
Immediately after towel drying
At least every 2 hours - INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
VERTRA S DORIAN KONA GOLD SIGNATURE FACE STICK SPF 38
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66990-1021 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) PARAFFIN (UNII: I9O0E3H2ZE) CERESIN (UNII: Q1LS2UJO3A) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM) HEXYLDECYL ISOSTEARATE (UNII: 3V20TC06U5) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66990-1021-1 11 g in 1 CARTON; Type 0: Not a Combination Product 12/18/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 12/18/2020 Labeler - Toshiki Pigment Co., ltd. (716140285) Establishment Name Address ID/FEI Business Operations Toshiki Pigment Co., ltd. 716140285 manufacture(66990-1021)
