FACE AND BODY SPF 30- avobenzone,octinoxate,octocrylene,oxybenzone,titanium dioxide, zinc oxide 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

AVOBENZONE

OCTINOXATE

OCTOCRYLENE

OXYBENZONE

ZINC OXIDE

TITANIUM DIOXIDE

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

WARNINGS

For external use only

Do not use damaged or broken skin

Stop use and ask doctor if rash occurs

When using this product, keep out of eyes. Rinse with water to remove

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

DIRECTIONS

apply liberally 15 minutes before sun exposure

reapply: at least every 2 hours, immediately after towel drying

use a 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 skin cancer and early skin aging. To decrease this risk, regularly use 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

INACTIVE INGREDIENTS

ammonium acryloydimethyltaurate vp copolymer, bixa orellana seed extract, benzyl alcohol, bis-ethylhexyloxyphenol methoxyphenyl triazine, caprylic-capric triglyceride, cetaryl alcohol, citronellol, coumarin, c12-15 alkyl benzoate, decyl glucose, diisopropyl sebacate, dimethicone, dimethiconol behenate, ethylhexlglycerin, glycerin, glyceryl stearate, hexyl cinnamal, hydrolyzed soy protein, hydrolyzed wheat protein, limonene, linalool, menthylene bis-benzotriazoyl tetramethybutyphenol (nano), parfum, peg-100 stearate, propylene glycol, menthyl lactate, silica, tocopheryl acetate, tocopherol, tripeptide-1, vp-eicosene copolymer, water, xanthan gum

OTHER INFORMATION

Protect this product from excessive heat and direct sun

SUNSCREEN LABEL

SUNSCREEN 22 SPF 30.jpg

INGREDIENTS AND APPEARANCE

FACE AND BODY  SPF 30
avobenzone,octinoxate,octocrylene,oxybenzone,titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73310-3022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1 mg  in 5 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1 mg  in 5 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1 mg  in 5 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1 mg  in 5 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 mg  in 5 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
PEG-100 STEARATE (UNII: YD01N1999R)	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: 73310-3022-3	150 mL in 1 CONTAINER; 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(73310-3022)