Rose All Day Moisturizer 11041, 71413-210

Rose All Day Moisturizer by

Drug Labeling and Warnings

Rose All Day Moisturizer by is a Otc medication manufactured, distributed, or labeled by Baja Fur, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ROSE ALL DAY MOISTURIZER SPF 30- avobenzone, homosalate, octinoxate, octocrylene cream 
Baja Fur, S.A. de C.V.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Rose All Day Moisturizer 11041, 71413-210

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

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71413-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	36 mg  in 1 g
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71413-210-02	1 in 1 CARTON	01/01/2019
1	NDC: 71413-210-01	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 - Baja Fur, S.A. de C.V. (821533098)

Revised: 9/2021

Document Id: cd3e268d-cf1e-3a4a-e053-2a95a90acfea

34390-5

Set id: cd3e65d2-b39a-7989-e053-2a95a90a2790

Version: 1

Effective Time: 20210930