ROSE ALL DAY MOISTURIZER SPF 30- avobenzone, homosalate, octinoxate, octocrylene cream

Rose All Day Moisturizer by

Drug Labeling and Warnings

Rose All Day Moisturizer by is a Otc medication manufactured, distributed, or labeled by LINA GALE, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3%

Homosalate 5%

Octinoxate 7.5%

Octocrylene 3.6%

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 dskin 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.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control Center right away

Directions

apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2p.m. wear long-sleeved shirts, pants, hats, and sunglasses

Other information

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

Inactive ingredients

Water/Eau, Rosa Damascena Flower Water, Diethylhexyl 2,6-Naphthalate, Caprylic/Capric Triglyceride, Dimethicone, Stearyl Alcohol, Tribehenin, Glycerin, Steareth-2, Steareth-20, Hydrogenated Coco-Glycerides, Octyldodecanol, Pullulan, Phenoxyethanol, Dimethiconol, Fragrance/Parfum, Polysorbate 20, Xanthan Gum, Caprylyl Glycol, Terminalia Ferdinandiana Fruit Extract, Ethylhexylglycerin, Hexylene Glycol, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Lycium Barbarum Fruit Extract, Potassium Sorbate, Citric Acid, Sodium Benzoate, Leuconostoc/Radish Root Ferment Filtrate, BHT, Mica, Red 40 (CI 16035), Titanium Dioxide (CI 77891).

Questions or comments?

Call 1-800-227-0333 (USA only) or www.PhysiciansFormula.com

Package Label

INGREDIENTS AND APPEARANCE

ROSE ALL DAY MOISTURIZER  SPF 30
avobenzone, homosalate, octinoxate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69514-127
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	50 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	36 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
DIMETHICONOL (40 CST) (UNII: 343C7U75XW)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARETH-20 (UNII: L0Q8IK9E08)
XANTHAN GUM (UNII: TTV12P4NEE)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
DIMETHICONE 100 (UNII: RO266O364U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
ROSA DAMASCENA FLOWER (UNII: JWB78P295A)
GLYCERIN (UNII: PDC6A3C0OX)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
MICA (UNII: V8A1AW0880)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
STEARETH-2 (UNII: V56DFE46J5)
PULLULAN (UNII: 8ZQ0AYU1TT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIBEHENIN (UNII: 8OC9U7TQZ0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69514-127-02	1 in 1 CARTON	01/01/2019
1	NDC: 69514-127-01	34 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2019

Labeler - LINA GALE, INC (078890119)