Label: GREEN SUNBLOCK- zinc oxide cream
Contains inactivated NDC Code(s)
NDC Code(s): 71547-104-01, 71547-104-02
- Packager: Iruri Nature Handmade Soap & Cosmetic Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Updated July 24, 2017
If you are a consumer or patient please visit this version.
- Active Ingredients
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
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
Children under 6 months of age: ask a doctor
- Inactive Ingredients
- Green Sunblock (Camellia oil & Pumpkin seed oil)
INGREDIENTS AND APPEARANCE
zinc oxide cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71547-104 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 PUMPKIN SEED OIL (UNII: 6E5QR5USSP) GRAPE SEED OIL (UNII: 930MLC8XGG) GLYCERIN (UNII: PDC6A3C0OX) CASTOR OIL (UNII: D5340Y2I9G) ALLANTOIN (UNII: 344S277G0Z) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71547-104-02 1 in 1 PACKAGE 07/24/2017 1 NDC:71547-104-01 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 07/20/2017 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(71547-104)