NDC | 71547-111-01, 71547-111-02 |
Set ID | 552ad082-747b-1b97-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | Iruri Nature Handmade Soap & Cosmetic Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active Ingredients
- Purpose
- Uses
-
Warnings
For external use only
Do not use when skin is red, inflamed, irritated, or painful
When using this product
- do not apply on other parts of the body
- do not use on damaged or broken skin
- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
- do not apply directly to wound or open cut
Stop use and ask a doctor if
- Rash or irritation on skin develops and lasts
- Keep out of reach of children
-
Directions
1. Apply the adequate amount on the palm of the hands and pat lightly with the fingertips.
2. Apply liberally 15 minutes before sun exposure.
3. Reapply at least every 2 hours.
4. Use a water-resistant sunscreen if swimming or sweating.
5. 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:
1) Limit time in the sun, especially from 10 a.m.- 2 p.m.
2) Wear long-sleeved shirts, pants, hats, and sunglasses.
6. Children under 6 months of age: ask a doctor
- Inactive Ingredients
- Purple Sunblock (Grape seed & Argan oil Sunblock)
-
INGREDIENTS AND APPEARANCE
PURPLE SUNBLOCK
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71547-111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.6 g in 20 mL Inactive Ingredients Ingredient Name Strength ARGAN OIL (UNII: 4V59G5UW9X) CASTOR OIL (UNII: D5340Y2I9G) WATER (UNII: 059QF0KO0R) GRAPE SEED OIL (UNII: 930MLC8XGG) ALLANTOIN (UNII: 344S277G0Z) GLYCERIN (UNII: PDC6A3C0OX) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71547-111-02 1 in 1 PACKAGE 07/25/2017 1 NDC:71547-111-01 20 mL in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/25/2017 Labeler - Iruri Nature Handmade Soap & Cosmetic Inc (095675041) Registrant - Iruri Nature Handmade Soap & Cosmetic Inc (095675041) Establishment Name Address ID/FEI Business Operations Iruri Nature Handmade Soap & Cosmetic Inc 095675041 manufacture(71547-111)