SPA COLOGY ULTRA SHEER FACE AND BODY SUNSCREEN SPF 70- avobenzone, homosalate,octisalate,octocrylene,oxybenzone stick

Spa Cology Ultra Sheer Face and Body Sunscreen SPF 70 by

Drug Labeling and Warnings

Spa Cology Ultra Sheer Face and Body Sunscreen SPF 70 by is a Otc medication manufactured, distributed, or labeled by FRUIT OF THE EARTH, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%,

Homosalate 15%,

Octisalate 5%,

Octocrylene 10%,

Oxybenzone 3%

Purpose

Sunscreen

Uses

helps prevent sunburn if used 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

on damaged or broken skin.

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

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure

reapply:

after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

children under 6 months of age: 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 time in the sun, especially from 10 a.m. - 2 p.m.

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

Other information

protect the product in this container from excessive heat and direct sun

may stain or damage some fabrics, materials or surfaces

Inactive ingredients

adipic adic/diglycol crosspolymer, beeswax, BHT, butyloctyl salicylate, C12-15 alkyl benzoate, caprylyl glycol, dimethicone, fragrance, neopentyl glycol diethylhexanoate, neopentyl glycol diisostearate, octydodecyl neopentanoate, ozokerite, paraffin, polyethylene, silica

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPA COLOGY ULTRA SHEER FACE AND BODY SUNSCREEN SPF 70 
avobenzone, homosalate,octisalate,octocrylene,oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62217-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CERESIN (UNII: Q1LS2UJO3A)
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE (UNII: 92RU3N3Y1O)
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)
NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PARAFFIN (UNII: I9O0E3H2ZE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62217-060-36	42 g in 1 TUBE; Type 0: Not a Combination Product	12/06/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/06/2016

Labeler - FRUIT OF THE EARTH, INC. (079559467)