NDC | 71014-010-01, 71014-010-02 |
Set ID | 3a2120e9-e07e-4225-bede-6736a8908d1b |
Category | HUMAN OTC DRUG LABEL |
Packager | Eai-Jr286, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
-
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
-
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
- immediately after towel drying
- at leasty 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 15 or higher and other 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
-
INGREDIENTS AND APPEARANCE
FOUNDATION BROAD SPECTRUM SPF 35 COOLY BEIGE VERTRA
titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71014-010 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 ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) HEXYLDECYL ISOSTEARATE (UNII: 3V20TC06U5) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) 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:71014-010-02 1 in 1 BOX 10/07/2016 1 NDC:71014-010-01 11 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) Establishment Name Address ID/FEI Business Operations Toshiki Pigment Co., ltd. 716140285 manufacture(71014-010)