Label: EHUKAI BEIGE FOUNDATION SUNSCREEN FACE BROAD SPECTRUM SPF 38- titanium dioxide stick
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Contains inactivated NDC Code(s)
NDC Code(s): 71014-020-01 - Packager: Eai-jr 286, 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
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- apply liberally and evenly 15 minutes before sun exposure
- 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
- 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 value 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m.-2p.m.
- wear long-sleeve shirts, pants, hats and sunglasses
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EHUKAI BEIGE FOUNDATION SUNSCREEN FACE BROAD SPECTRUM SPF 38
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71014-020 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 TOCOPHEROL (UNII: R0ZB2556P8) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) MICA (UNII: V8A1AW0880) PARAFFIN (UNII: I9O0E3H2ZE) CERESIN (UNII: Q1LS2UJO3A) HEXYLDECYL ISOSTEARATE (UNII: 3V20TC06U5) SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71014-020-01 11 g in 1 BOX; Type 0: Not a Combination Product 02/14/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/14/2018 Labeler - Eai-jr 286, Inc (827896718) Establishment Name Address ID/FEI Business Operations Toshiki Pigment Co., Ltd 716140285 manufacture(71014-020)
