SUN SPR SPF 50- avobenzone,octinoxate,octocrylene,oxybenzone,titanium dioxide spray

SUN SPR by

Drug Labeling and Warnings

SUN SPR 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

TITANIUM DIOXIDE

PURPOSE

Sunscreen

USES

helps prevent sunburn

use as directed with other sun protection measures (see Directions), decrease 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

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

1apply liberally 15 minutes before the sun exposure

reapplyat 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 a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measures including

limit the time in the sun, especially from 10 a.m. - 2p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

1 SUNSCREEN 5033 BODY SPRAY SPF 50.jpg

INACTIVE INGREDIENTS

alcohol, BHT, bis-ethylhexyloxyphenol methoxphenyl triazine, butyrospermum parkii butter extract, caprylic - capric triglyceride, carthamus tinctorius seed oil, cellulose gum, citronellol, coumarin, cyclomethicone, c12-15 alkyl benzoate, decyl glucose, diisopropyl sebacate, dimethicone, glycerin, hexyl cinnamal, coumarin, hydrolyzed soy protein, hydrolyzed whaet protein, lecithin, limnanthes alba seed oil, limonene, linalool, methylene bis-benzotriazoly tetramethybutyphenol (nano), methylisothizolinone, menthyl lactate, microcrystalline cellulose, olea europapea oil unsonifiables, parfum, phenoxyhetanol, potassium cetyl phosphate, propylene gycol, silica, tocopheryl acetate, tripeptide-1, vp-eicosene copolymer, water, xanthan gum

STORAGE AND HANDLING

Protect this product from excessive heat and direct sun

PRINCIPAL LABEL

SUNSCREEN 5033 BODY SPF50.jpg

INGREDIENTS AND APPEARANCE

SUN SPR  SPF 50
avobenzone,octinoxate,octocrylene,oxybenzone,titanium dioxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73310-5033
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1 mg  in 5 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	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: 73310-5033-3	150 mL in 1 BOTTLE, SPRAY; 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(73310-5033)