Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
Raining Rose, Inc.
TOPICAL
OTC DRUG
Sunscreen - Helps prevent sunburn - Do not use on damaged or broken skin Stop use and as a doctor if • rash occurs
OTC monograph final
SPF 30 MINERAL SUN STICK- ZINC OXIDE STICK RAINING ROSE, INC. _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._ ---------- SPF 30 MINERAL SUN STICK _DRUG FACTS_ ACTIVE INGREDIENTS: Zinc Oxide 18.0% _PURPOSE_ Sunscreen _USES_ Helps prevent sunburn WARNINGS FOR EXTERNAL USE ONLY DO NOT USE on damaged or broken skin STOP USE AND AS A DOCTOR if • rash occurs WHEN USING THIS PRODUCT • Keep out of eyes. Rinse well with water to remove. Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away. DIRECTIONS •Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months of age: ASK A DOCTOR 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 protection measures including: • limit time in the sun, especially from 10a.m. - 2p.m. • wear long sleeved shirts, pants, hat, and sunglasses. INACTIVE INGREDIENTS: Sunflower Seed Oil*, Beeswax*, Olive Oil*, Tocopherol, aloe vera leaf extract, canola oil. *Organic Ingredient OTHER INFORMATION: Protect this product from excessive heat and direct sun. PRODUCT PACKAGE LABELING PEEL HERE FOR DRUG FACTS _BROAD SPECTRUM_ _SPF 30 MINERAL SUN STICK_ Made in the USA Net Wt. 0.6.oz. DIST. BY: Raining Rose, Inc., Cedar Rapids, IA 52403 L000000 SAFETY SEAL res SPF 30 MINERAL SUN STICK Raining Rose, Inc. zinc oxide stick PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 56 9 2-0 8 48 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37) ZINC CATION 3.0 6 g in 17 g INACTIVE INGREDIE Lire le document complet