SWEET PEA SHEER SHIELD SPF45- avobenzone 3.0%, homosalate 10.0%, octisalate 5.0%, octocrylene 10.0% lotion

Facial Sheer Shield SPF45 by

Drug Labeling and Warnings

Facial Sheer Shield SPF45 by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc., The Hain Celestial Group, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DOSAGE & ADMINISTRATION

PURPOSE

WARNINGS

KEEP OUT OF REACH OF CHILDREN

INACTIVE INGREDIENT

INDICATIONS & USAGE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SWEET PEA SHEER SHIELD SPF45 
avobenzone 3.0%, homosalate 10.0%, octisalate 5.0%, octocrylene 10.0% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-0969
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
XANTHAN GUM (UNII: TTV12P4NEE)
LIMONENE, (+/-)- (UNII: 9MC3I34447)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
DIMETHICONE (UNII: 92RU3N3Y1O)
ORANGE OIL (UNII: AKN3KSD11B)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
GINKGO BILOBA LEAF OIL (UNII: Y5967KO1JH)
.ALPHA.-AMYLCINNAMALDEHYDE, (E)- (UNII: 86L63D4ZJ7)
GERANIOL (UNII: L837108USY)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
LINALYL ACETATE (UNII: 5K47SSQ51G)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SQUALANE (UNII: GW89575KF9)
ALCOHOL (UNII: 3K9958V90M)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMOMILE (UNII: FGL3685T2X)
LATHYRUS ODORATUS FLOWER (UNII: X3AJ4A1O73)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-0969-3	85 g in 1 TUBE; Type 0: Not a Combination Product	12/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/06/2019

Labeler - The Hain Celestial Group, Inc. (117115556)

Registrant - The Hain Celestial Group, Inc (014334364)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		117115556	manufacture(61995-0969)