Label: TRANSLUCENT BROAD SPECTRUM FOUNDATION SPF 50 VERTRA- padimate o, titanium dioxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 71014-005-01, 71014-005-02 - Packager: Eai-Jr286, Inc.
- 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 January 8, 2020
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- Official Label (Printer Friendly)
- 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 evenly 15 minutes before sun exposure
- apply to all skin exposed to sun
- use a water resistant sunscreen if swimming or sweating
- reapply: after 80 minutes of swimming or sweating
- immeadiately after towel drying
- 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 otther sun protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months of age: ask a doctor
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TRANSLUCENT BROAD SPECTRUM FOUNDATION SPF 50 VERTRA
padimate o, titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71014-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O 7 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 17.45 g in 100 g Inactive Ingredients Ingredient Name Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) HEXYLDECYL ISOSTEARATE (UNII: 3V20TC06U5) MICA (UNII: V8A1AW0880) CERESIN (UNII: Q1LS2UJO3A) PARAFFIN (UNII: I9O0E3H2ZE) STEARIC ACID (UNII: 4ELV7Z65AP) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71014-005-02 1 in 1 BOX 10/07/2016 1 NDC:71014-005-01 10.5 g in 1 CYLINDER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/07/2016 Labeler - Eai-Jr286, Inc. (827896718) Registrant - Eai-Jr286, Inc. (827896718) Establishment Name Address ID/FEI Business Operations Toshiki Pigment Co., ltd. 716140285 manufacture(71014-005)
