ROSE INC. SOLAR POWER LUMINOUS SERUM SPF30- zinc oxide lotion

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredients

Zinc Oxide 14%

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 signs of aging caused by the sun.

Warnings

For external use only

Do not use

on damaged of 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 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROSE INC. SOLAR POWER LUMINOUS SERUM  SPF30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73517-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	14 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)
COCO-CAPRYLATE (UNII: 4828G836N6)
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
SQUALANE (UNII: GW89575KF9)
DICRATERIA ROTUNDA OIL (UNII: Z0DWU9R4GM)
ASTAXANTHIN (UNII: 8XPW32PR7I)
LAUROYL LYSINE (UNII: 113171Q70B)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
ETHYL FERULATE (UNII: 5B8915UELW)
ISOSTEARIC ACID (UNII: X33R8U0062)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
LEVOMENOL (UNII: 24WE03BX2T)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
RUTTNERA LAMELLOSA OIL (UNII: 5XZ38R4SUT)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SUCROSE (UNII: C151H8M554)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ARGAN OIL (UNII: 4V59G5UW9X)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
BRASSICA NAPUS WHOLE (UNII: NFP6814VZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73517-501-02	1 in 1 CARTON	01/01/2023
1	NDC: 73517-501-01	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 73517-501-03	1 in 1 CARTON	01/01/2023
2	NDC: 73517-501-04	10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	01/01/2023

Labeler - Amyris, Inc (185930182)