ROSEASE BY ANNA LOTAN GENTLE DAYTIME BROAD SPECTRUM SPF 30- octinoxate, zinc oxide cream

Rosease By Anna Lotan Gentle Daytime Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Rosease By Anna Lotan Gentle Daytime Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Anna Lotan Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS:

ACTIVE INGREDIENTS:

Octinoxate 7.5%
Zinc Oxide 10.0%

Purpose

Sunscreen

USES:

Helps prevent sunburn.

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.

DIRECTIONS:

Apply to all skin exposed to the sun. Apply liberally and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use water-resistant sunscreen if swimming or sweating. For 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 sun from 10 a.m.- 2 p.m.
wear long-sleeved shirts, pants, hats and sunglasses.

INACTIVE INGREDIENTS:

water (aqua), butyloctyl salicylate, glycerin, dimethicone, styrene/acrylates copolymer, coco-caprylate/caprate, caprylic/capric triglyceride, vp/eicosene copolymer, carthamus tinctorius oleosomes, elettaria cardamomum seed extract, aloe barbadensis leaf juice, tocopheryl acetate, perilla frutescens extract, pyrus malus (apple) fruit extract, rose extract, santalum album extract, camellia sinensis leaf extract, anthemis nobilis flower extract, cananga odorata flower extract, citrus aurantium dulcis (orange) peel extract, cucumis melo (melon) fruit extract, cucumis sativus fruit extract, jasminum officinale flower/leaf extract, lavandula angustifolia (lavender) flower / leaf / stem extract, rubus idaeus (raspberry) fruit extract, polygonum aviculare extract, vitis vinifera fruit cell extract, propanediol, cetearyl alcohol, pentylene glycol, arachidyl alcohol, polyhydroxystearic acid, cocoglucoside, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, behenyl alcohol, xanthan gum, triethoxycaprylylsilane, arachidyl glucoside, phenethyl alcohol, caprylyl glycol.

OTHER INFORMATION:

Protect the product in this container from excessive heat and direct sun.

QUESTIONS OR COMMENTS?

(781) 281-0954

SPL UNCLASSIFIED SECTION

ENRICHED WITH BOTANICAL EXTRACTS

EXCELLENT SKIN TOLERANCE

FREE RADICAL PROTECTION

For All Skin Types

8

DERMATOLOGICALLY TESTED
TENDER LOVING CARE
NON-IRRITATING

THE ROSEASE TOOLKIT

Distributed by:
Anna Lotan USA Inc.
16 Wheeling Ave.
Woburn, MA 01801
www.annalotanusa.com

Packaging

INGREDIENTS AND APPEARANCE

ROSEASE BY ANNA LOTAN GENTLE DAYTIME BROAD SPECTRUM SPF 30 
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76446-648
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
CARDAMOM (UNII: 8BC4CUT4JL)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
APPLE (UNII: B423VGH5S9)
ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)
SANDALWOOD (UNII: 3641YW25N2)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)
ORANGE PEEL (UNII: TI9T76XD44)
MUSKMELON (UNII: ZV095H5633)
CUCUMBER (UNII: YY7C30VXJT)
JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
RASPBERRY (UNII: 4N14V5R27W)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
VITIS VINIFERA HIGH TANNIN CULTIVAR FRUIT CELL LYSATE (UNII: ZLW3M94UYA)
PROPANEDIOL (UNII: 5965N8W85T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
COCO GLUCOSIDE (UNII: ICS790225B)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
DOCOSANOL (UNII: 9G1OE216XY)
XANTHAN GUM (UNII: TTV12P4NEE)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76446-648-75	1 in 1 CARTON	05/25/2022
1		75 mL 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 final	part352	05/25/2022

Labeler - Anna Lotan Ltd (600458368)