FDA.reportPublic FDA data

Rose Inc. Solar Power Luminous Serum

Manufacturer
Amyris, Inc
Effective date
2023-01-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:39:47

Label at a glance#

ProductRose Inc. Solar Power Luminous Serum SPF30
Active ingredientZINC OXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn if used as directed with other sun protection measures (see ​Directions) ​, decreases the risk of skin cancer and early signs of aging caused by the sun.

Dosage and administration

Apply generously 15 minutes before sun exposure reapply at least every 2 hours ​Sun Protection Measures ​Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularyly use a sunscreen with a Broad Spectrum value of SPF 15 or higher and other sun protection measures including Limit time in the sun, especially from 10 a.m.- 2 p.m. wear long-sleeved shirts, pants, ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 14%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

if used as directed with other sun protection measures (see ​Directions)​, decreases the risk of skin cancer and early signs of aging caused by the sun.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged of broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes.  Rinse with water to remove

Stop use and ask

OTC - STOP USE SECTION

a doctor if rash occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply generously 15 minutes before sun exposure
  • reapply at least every 2 hours
  • ​Sun Protection Measures ​Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularyly use a sunscreen with a Broad Spectrum value of SPF 15 or higher and other sun protection measures including
  • Limit time in the sun, especially from 10 a.m.- 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses
  • use a water-resistant sunscreen if swimming or sweating
  • children under 6 months of age:ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Squalane, Coco-Caprylate, Caprylic/Capric Triglyceride, Propanediol, Brassica Napus Oleifera Extract, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Polyhydroxystearic Acid, Ethyl Ferulate, Bisabolol, Polygonum Aviculare Extract, Dicrateria Rotunda Oil, Ruttnera Lamellosa Oil, Stearalkonium Bentonite, Polyglyceryl-3 Polyricinoleate, Lecithin, Tocopheryl Acetate, Hydroxyacetophenone, Saccharomyces Ferment, Argania Spinosa Kernel Oil, Glycerin, Lauroyl Lysine, Sucrose, Astaxanthin, 1,2-Hexanediol, Caprylyl Glycol, Triethyl Citrate, Isostearic Acid, Sodium Chloride

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30ml Rose Serum UC30ml Rose Serum UC

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73517-50173517-501-01, 73517-501-02, 73517-501-04, 73517-501-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
SACCHAROMYCES LYSATER85W246Z1CIACT
COCO-CAPRYLATE4828G836N6IACT
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
SQUALANEGW89575KF9IACT
DICRATERIA ROTUNDA OILZ0DWU9R4GMIACT
ASTAXANTHIN8XPW32PR7IIACT
LAUROYL LYSINE113171Q70BIACT
POLYGONUM AVICULARE TOPZCD6009IUFIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
ETHYL FERULATE5B8915UELWIACT
ISOSTEARIC ACIDX33R8U0062IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
LEVOMENOL24WE03BX2TIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
CAPRYLYL GLYCOL00YIU5438UIACT
RUTTNERA LAMELLOSA OIL5XZ38R4SUTIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
SUCROSEC151H8M554IACT
ZINC OXIDESOI2LOH54ZACTIM
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE687U3PEB2YIACT
PROPANEDIOL5965N8W85TIACT
SODIUM CHLORIDE451W47IQ8XIACT
ARGAN OIL4V59G5UW9XIACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
BRASSICA NAPUS WHOLENFP6814VZ4IACT

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
f2f6c217-5c45-7b5c-e053-2995a90a50f1f2f6b208-ea9f-f8b9-e053-2a95a90ae4d82023-01-23WarningsExact identifier
spl id: f2f6c217-5c45-7b5c-e053-2995a90a50f1
spl set id: f2f6b208-ea9f-f8b9-e053-2a95a90ae4d8

Reported adverse events (FAERS/openFDA)#

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