Country: United States
Language: English
Source: NLM (National Library of Medicine)
Active ingredients Purpose, Homosalate..................................Sunscreen, Octyl methoxycinnamate..............Sunscreen, Benzophenone-3..........................Sunscreen, Titanium dioxide...........................Sunscreen
Davemed Healthcare Co., Ltd
TOPICAL
OTC DRUG
Active ingredients Purpose Homosalate..................................Sunscreen Octyl methoxycinnamate..............Sunscreen Benzophenone-3..........................Sunscreen Titanium dioxide...........................Sunscreen Uses - Helps prevent sunburn - Higher SPF gives more protection - For skin highly sensitive to sunburn
OTC monograph not final
SUNSCREEN CREAM SPF 30- HOMOSALATE, OCTYL METHOXYCINNAMATE, BENZOPHENONE-3, TITANIUM DIOXIDE CREAM DAVEMED HEALTHCARE CO., 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._ ---------- SUNSCREEN CREAM SPF 30 ACTIVE INGREDIENTS Active ingredients Purpose Ho mo salate..................................Sunscreen Octyl methoxycinnamate..............Sunscreen Benzophenone-3..........................Sunscreen Titanium dioxide...........................Sunscreen PURPOS E _ACTIVE INGREDIENTS PURPOSE_ Ho mo salate..................................Sunscreen Octyl methoxycinnamate..............Sunscreen Benzophenone-3..........................Sunscreen Titanium dioxide...........................Sunscreen US ES US ES Helps prevent sunburn Higher SPF gives more protection For skin highly sensitive to sunburn FOR EXTERNAL USE ONLY WHEN USING THIS PRODUCT Keep out eyes. Rinse with water to remove STOP USE AND ASK A DOCTOR if rash or irritation develops and lasts KEEP OUT OF REACH OF CHILDREN KEEP OUT OF REACH OF CHILDREN if swallowed, contact a poison control center or doctor right away DIRECTIONS Apply liberally before sun exposure and as needed Children under 6 months of age: ask a doctor INACTIVE INGREDIENTS Water, Cetearyl Alcohol, Glycerin monosteareate Gctt, Propylparaben, Methylparaben, glycerol, EDTA-2NA, Vinylchloride-methylacrylate, copolymer, Methylisothiazolinone OTHER INFORMATION OTHER INFORMATION Store at room temperature PRINCIPAL DISPLAY PANEL SUNSCREEN CREAM SPF 30 homosalate, octyl methoxycinnamate, benzophenone-3, titanium dioxide cream PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:70 8 9 7-0 0 8 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S) HOMOSALATE 4 g in 10 0 mL TITANIUM DIO XIDE (UNII: 15F Read the complete document