FDA.reportPublic FDA data

Rosease By Anna Lotan Gentle Daytime Broad Spectrum SPF 30

Manufacturer
Anna Lotan Ltd
Effective date
2026-03-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:49:48

Label at a glance#

ProductRosease By Anna Lotan Gentle Daytime Broad Spectrum SPF 30
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

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 ...

Storage and handling

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%
Zinc Oxide 10.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

USES:

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

WARNINGS:

WARNINGS SECTION

For external use only.

Do not useon damaged or broken skin.

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

Stop use and ask a doctorif rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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:

INACTIVE INGREDIENT SECTION

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:

STORAGE AND HANDLING SECTION

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

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

(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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850034338002GTIN-13: 0850034338002
EAN-13: 0850034338002
GTIN-12: 850034338002
UPC-A: 850034338002
GTIN storage (14 digits): 00850034338002		76446648-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76446-648-75Rosease By Anna Lotan Gentle Daytime Broad Spectrum SPF 301 in 1 CARTONCREAM13
76446-648-75Rosease By Anna Lotan Gentle Daytime Broad Spectrum SPF 3075 mL in 1 BOTTLE, PUMPCREAM753

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76446-64876446-648-75

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
CARTHAMUS TINCTORIUS SEED OLEOSOMES9S60Q72309IACT
CARDAMOM8BC4CUT4JLIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PERILLA FRUTESCENS LEAFT4L5881Y68IACT
APPLEB423VGH5S9IACT
ROSA CENTIFOLIA FLOWERCS4TE8FF7OIACT
SANDALWOOD3641YW25N2IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CHAMAEMELUM NOBILE FLOWERO2T154T6OGIACT
CANANGA ODORATA FLOWER76GTF6Z97MIACT
ORANGE PEELTI9T76XD44IACT
MUSKMELONZV095H5633IACT
CUCUMBERYY7C30VXJTIACT
JASMINUM OFFICINALE FLOWER0Q8K841432IACT
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP9YT4B71U8PIACT
RASPBERRY4N14V5R27WIACT
POLYGONUM AVICULARE TOPZCD6009IUFIACT
VITIS VINIFERA HIGH TANNIN CULTIVAR FRUIT CELL LYSATEZLW3M94UYAIACT
PROPANEDIOL5965N8W85TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
PENTYLENE GLYCOL50C1307PZGIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
COCO GLUCOSIDEICS790225BIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
DOCOSANOL9G1OE216XYIACT
XANTHAN GUMTTV12P4NEEIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
CAPRYLYL GLYCOL00YIU5438UIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4cbc076c-14bc-d065-e063-6294a90ac8d4c9e1afe1-4b1d-42d0-a1fe-b554adeaf8112026-03-11WarningsExact identifier
spl id: 4cbc076c-14bc-d065-e063-6294a90ac8d4
spl set id: c9e1afe1-4b1d-42d0-a1fe-b554adeaf811

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.