FACE AND BODY SPF 15- octinoxate, oxybenzone, avobenzone cream

Face and Body by

Drug Labeling and Warnings

Face and Body by is a Otc medication manufactured, distributed, or labeled by AGEFARM SRL, COSMESIT Srl. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Octinoxate

Oxybenzone

Avobenzone

PURPOSE

Sunscreen

USES

Helps prevent sunburn

Use as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

WARNING

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 product 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 a water-resistant sunscreen if swimming or sweating

SUN PROTECTION MEASURES. Spending time in the sun increases your risk of skin cancer and early skin aging.

To decrease this risk,regulary 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-sleaved shirts, pants, hats, and sunglusses

Children under 6 months. Ask a doctor

INACTIVE INGREDIENTS

water, C12-15 alkyl benzoate, disopropyl sebacate, isononyl isononanoate, squalane, glyceril stearate, cocos nucifera oil, cetearyl alcohol, propylene glycol, peg-100 stearate, glycerin, dimethicone, vp/eicosene copolymer, calendula officinalis flower extract, ammonium acryloyldimethyltaurate, vp/copolymer, bixia orellana seed extract, hydrolyzed wheat protein, hydrolyzed soy protein, tocopherol, tocopheryl acetate, tripeptide-10 citrulline, caprylic/capric triglyceride, xanthan gum, pseudoalteromonas ferment extract, tripeptide-1, lecithin, carbomer, triethanolamine, benzyl alcohol, dimethiconol behenate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, diethylhexyl syringylidenemalonate, parfum, hexyl cinnamal, coumarin, limonene, linalool, citronellol, menthyl lactate, ethylhexylglycerin, polysorbate 60

STORAGE

Protect this container from heat and sun

SUNSCREEN LABEL

SCREEN 1510 SPF 15

INGREDIENTS AND APPEARANCE

FACE AND BODY  SPF 15
octinoxate, oxybenzone, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73310-1522
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1 mg  in 5 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 mg  in 5 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)	1 mg  in 5 mL

Product Characteristics
Color	white (Cream)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73310-1522-3	150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/28/2019

Labeler - AGEFARM SRL (439202467)

Establishment
Name	Address	ID/FEI	Business Operations
COSMESIT Srl		339071951	manufacture(73310-1522)