Country: United States
Language: English
Source: NLM (National Library of Medicine)
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)
Kamins Dermatologics Inc.
AVOBENZONE
AVOBENZONE 25 mg in 1 mL
TOPICAL
OTC DRUG
Purpose: Sunscreen A LIGHT, SILKY LOTION THAT DIFFUSES A BLEND OF MOISTURIZERS, ANTI-OXYDANT VOTMINS INTO THE SKIN TO ENHANCE DAY LONG COMFORT AND HYDRATION. THE SKIN'S OUTER LAYERS ARE COVERED WITH A PROTECTIVE SHIELD, PRODUCING A HEALTHY, LUMINESCENT GLOW. Uses ■ Helps prevent sunburn. ■ Higher SPF gives more sunburn protection. ■ Provides moderate protection against sunburn.
OTC monograph final
DAY L- AVOBENZONE OCTISALATE OCTINOXATE LOTION KAMINS DERMATOLOGICS 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._ ---------- CONSUMER LABELING Active ingredients: AVOBENZONE 2.5 % OCTINOXATE 7.5 % OCTISALATE 4.0 % Purpose: Sunscreen Keep out of the reach of children. A LIGHT, SILKY LOTION THAT DIFFUSES A BLEND OF MOISTURIZERS, ANTI-OXYDANT VOTMINS INTO THE SKIN TO ENHANCE DAY LONG COMFORT AND HYDRATION. THE SKIN'S OUTER LAYERS ARE COVERED WITH A PROTECTIVE SHIELD, PRODUCING A HEALTHY, LUMINESCENT GLOW. Uses ■ Helps prevent sunburn. ■ Higher SPF gives more sunburn protection. ■ Provides moderate protection against sunburn. Warnings For external use only. When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove. Stop use and ask a doctor if rash or irritation develops and lasts. If swallowed, seek medical assistance or contact a Poison Control Center immediately. Directions: Apply liberally and evenly each morning to cleansed face and neck, before sun exposure and as needed. Children under 6 months of age: ask a doctor. Inactive ingredients: aqua/water/eau, acer saccharum (maple isolate), butylene glycol, hydrolyzed collagen, hydrolyzed elastin, octocrylene, cetyl alcohol, glyceryl stearate SE, ceteareth-12, cyclotetrasiloxane, cyclopentasiloxane, PEG/PPG-18/18 dimethicone, coco- caprylate/caprate, polysorbate-80, carbomer, tocopheryl acetate, retinyl palmitate, sodium hydroxide, phenoxyethanol, caprylyl glycol, sorbic acid, parfum/fragrance B. KAMINS DAY LOTION SPF15 50mL / 1.7 fl.oz DIN 02248016 DAY L avobenzone octisalate octinoxate lotion PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:63550-122 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 25 Read the complete document