Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
White & Elm LLC
TOPICAL
OTC DRUG
Do not use on damaged or broken skin.
OTC monograph final
WHITE AND ELM EVERYDAY SPF 15- ZINC OXIDE LOTION WHITE & ELM LLC _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._ ---------- ACTIVE INGREDIENT LISTING Active Ingredients: Zinc Oxide12%. Purpose: Sunscreen Children under 6 months of age: Ask a doctor. Inactive Ingredients: Aloe Barbadensis (Aloe Vera) Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Glycerin (Vegetable), Cetearyl Olivate, Benzyl Alcohol, Sorbitan Olivate, Tocopherols (Vitamin E), Xanthan Gum, Dehydroacetic Acid Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Do not use on damaged or broken skin. Keep out of children’s reach. Mineral Sunscreen Broad Spectrum SPF 15 WHITE AND ELM EVERYDAY SPF 15 zinc oxide lotion PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:70 8 40 -0 0 1 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 146 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH SUNFLO WER O IL (UNII: 3W1JG79 5YI) ALO E (UNII: V5VD430 YW9 ) CETEARYL O LIVATE (UNII: 58 B6 9 Q8 4JO) BENZYL ALCO HO L (UNII: LKG8 49 4WBH) TO CO PHERO L (UNII: R0 ZB2556 P8 ) XANTHAN GUM (UNII: TTV12P4NEE) GLYCERIN (UNII: PDC6 A3C0 OX) SO RBITAN O LIVATE (UNII: MDL271E3GR) DEHYDRO ACETIC ACID (UNII: 2KAG279 R6 R) PRODUCT CHARACTERISTICS COLOR white S CORE S HAP E S IZ E FLAVOR IMPRINT CODE CONTAINS PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:70 8 40 -0 0 1- 0 1 30 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n Pro duc t 0 2/0 9 /20 17 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph final pa rt352 0 2/0 9 /2 Prečítajte si celý dokument