FDA.reportPublic FDA data

ORGANIC ROSE FACE SUNSCREEN

Manufacturer
ALTEYA ORGANICS OOD
Effective date
2021-04-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:47:21

Label at a glance#

ProductORGANIC ROSE FACE SUNSCREEN
Active ingredientZINC OXIDE
Label structure10 sections

Storage and handling

Other information: • Store at temperatures between 70-90 o F/21-32 o C. Higher or lower temperatures may cause the product to separate or thicken. • May stain some fabrics.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Non-Nano Uncoated Zinc Oxide 20%

Purpose

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

Use: • Helps prevent sunburn. • If used as directed with other sun protection measures (see Directions), decreases the chance of skin cancer and early skin aging caused by the sun.

WARNINGS SECTION

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. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

• Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions: • Apply generously (2 mg/cm2 of skin) 15 minutes before sun exposure. • Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. • For 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 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2p.m. • wear long-sleeve shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Distilled Thermal Water, Helianthus Annuus (Sunflower) Seed Oil*, Cocos Nucifera (Coconut) Oil*, Glycerin*, Cucurbita Pepo (Pumpkin) Seed Oil*, Butyrospermum Parkii (Shea Butter)*, Simmondsia Chinensis (Jojoba) Oil*, Copernicia Cerifera (Carnauba Wax) *, Macadamia Integrifolia (Macadamia) Oil*, Caprylic/Capric Triglycerides, Polyglyceryl-6 Stearate (and) Polyglyceryl-6 Behenate , Isoamyl Laurate, Cera Alba (Beeswax)*, Lecithin*, Glyceryl Caprylate, Glyceryl Undecylenate, Cyamopsis Tetragonoloba (Guar) Gum*, Aloe Barbadensis (Aloe) Leaf Juice*, Persea Gratissima (Avocado) Oil*, Rosa Damascena (Rose) Flower Extract, Iron Oxides (CI 77492, CI 77491, CI 77499), Tocopherol (Vitamin E), Hippophae Rhamnoides (Seabuckthorn) Fruit Extract*, Calendula Officinalis (Flower) Extract*, Lavandula Angustifolia (Lavender) Oil*, Cymbopogon Martini (Palmarosa) Oil*, Anthemis Nobilis (Roman Chamomile) Flower Oil*, Linalool**, Geraniol**, Citronellol**, Eugenol**

* Certified Organic Ingredients
** Naturally occurring in essential oils

STORAGE AND HANDLING SECTION

Other information: • Store at temperatures between 70-90oF/21-32oC. Higher or lower temperatures may cause the product to separate or thicken. • May stain some fabrics.

SPL UNCLASSIFIED SECTION

AGE DEFENSE

BROAD SPECTRUM SPF 30

UVA/UVB 

SHEER TINT

CERTIFIED ORGANIC

No harmful chemical ingredients

Not Tested on Animals

Manufactured by Alteya Organics LLC.

Yagoda 6167. Made in Bulgaria.

www.AlteyaOrganics.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RoseFace1RoseFace1

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71330-10371330-103-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
SUNFLOWER OIL3W1JG795YIIACT
COCONUT OILQ9L0O73W7LIACT
GLYCERINPDC6A3C0OXIACT
PUMPKIN SEED OIL6E5QR5USSPIACT
SHEA BUTTERK49155WL9YIACT
JOJOBA OIL724GKU717MIACT
CARNAUBA WAXR12CBM0EIZIACT
MACADAMIA OIL515610SU8CIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYGLYCERYL-6 STEARATEETY9Q81E2TIACT
POLYGLYCERYL-6 BEHENATE4T2L7QI313IACT
ISOAMYL LAURATEM1SLX00M3MIACT
YELLOW WAX2ZA36H0S2VIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
GUAR GUME89I1637KEIACT
ALOEV5VD430YW9IACT
AVOCADO OIL6VNO72PFC1IACT
ROSA X DAMASCENA FLOWER OIL18920M3T13IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
TOCOPHEROLR0ZB2556P8IACT
HIPPOPHAE RHAMNOIDES FRUITAVL0R9111TIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
LAVENDER OILZBP1YXW0H8IACT
PALMAROSA OIL0J3G3O53STIACT
CHAMAEMELUM NOBILE FLOWER OILUB27587839IACT

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
9a930c0b-ecdf-45e8-897f-4b8ed78b7fef2fc5d475-3527-4ef3-bbca-c5a931caa0b62021-04-13WarningsExact identifier
spl id: 9a930c0b-ecdf-45e8-897f-4b8ed78b7fef
spl set id: 2fc5d475-3527-4ef3-bbca-c5a931caa0b6

Reported adverse events (FAERS/openFDA)#

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