NDC | 66990-1017-1, 66990-1017-2 |
Set ID | 5e29a5b2-5d7b-4c93-a65c-affe114f6b67 |
Category | HUMAN OTC DRUG LABEL |
Packager | Toshiki Pigment Co., ltd. |
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 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 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:66990-1017 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:66990-1017-2 1 in 1 CARTON 10/07/2016 1 NDC:66990-1017-1 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 - Toshiki Pigment Co., ltd. (716140285) Establishment Name Address ID/FEI Business Operations Toshiki Pigment Co., ltd. 716140285 manufacture(66990-1017)