Country: United States
Language: English
Source: NLM (National Library of Medicine)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
Emilia Personal Care Inc.
TOPICAL
OTC DRUG
Sunscreen - helps prevent sunburn - If used as directed with other sun protections measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun. - damaged or broken skin - if rash occurs
OTC monograph not final
SAFE HARBOR - NATURAL - SENSITIVE SPF50 BROAD SPECTRUM- TITANIUM DIOXIDE, ZINC OXIDE LOTION EMILIA PERSONAL CARE 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._ ---------- SAFE HARBOR NATURAL SUNCARE ACTIVE INGREDIENT Titanium Dioxide 10.4% Zinc Oxide 4.0% PURPOS E Sunscreen US ES helps prevent sunburn If used as directed with other sun protections measures (see _DIRECTIONS_), decreases 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 A DOCTOR if rash occurs KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use water resistant sunscreen if swimming or sweating Children under 6 months: ask a doctor SUN PROTECTION MEASURES: Spending time in the sun increases your risk of sun 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 10a.m. - 2p.m. limit time in the sun, especially from 10a.m. - 2p.m. wear long-sleeved shirts, pants, hats, and sunglasses OTHER INFORMATION protect the product in this container from excessive heat and direct sun INACTIVE INGREDIENTS water, cyclopentasiloxane, C12-15 alkyl benzoate, caprylic/capric triglyceride, glycerin, cetyl PEG/PPG-10/1 dimethicone, cetyl dimethicone, trimethoxycaprylylsilane, phenyl trimethicone, phenoxyethanol, ethylhexylglycerin, sodium chloride, hydrogenated castor oil, microcrystaline wax, tocopheryl acetate (vitamin E), allantoin, panthenol (pro-vitamin B5), lecithin, soy isoflavones, polysorbate 80, hippophae rhamnoides oil, bisabolol, c Read the complete document