Country: United States
Language: English
Source: NLM (National Library of Medicine)
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
ANTARIA PTY LTD
TOPICAL
OTC DRUG
SUNSCREEN - Helps prevent sunburn - If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by the sun
OTC monograph not final
ZINC FIVE-O SPF-50- ZINC OXIDE LOTION ANTARIA PTY LTD _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._ ---------- ZINC FIVE-O SPF-50 ACTIVE INGREDIENT ZINC OXIDE 25% PURPOSE SUNSCREEN USES Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by the sun WARNINGS For external use only 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 doctor if rash occurs. DIRECTIONS: Apply liberally and evenly 15 minutes before sun exposure. Reapply: • After 40 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 of 15 or higher and other sun protection measures including: •Limit time in the sun, especially from 10 a.m. – 2 p.m. •Wear long-sleeved shirts, pants, hats, and sunglasses •Children under 6 months of age: ask a doctor. OTHER INFORMATION Store at temperatures below 90°F. INACTIVE INGREDIENTS Coco-caprylate/caprate, glycerine, coconut alkane, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3-polyricinoleate, cera alba (beeswax), isostearic acid, polyhydroxy stearic acid, maltodextrin, phenylpropanol, propanediol, caprylyl glycol, tocopherol, ethylhexylglycerin, cetyl phosphate, sodium chloride, disodium EDTA ZINC FIVE-O SPF-50 zinc oxide lotion PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 0 39 6 -20 2 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 25 g in 10 0 mL INACTIVE INGRED Read the complete document