Roven SuperBloom Glow Defense Cream

Roven SuperBloom Glow Defense Cream by

Drug Labeling and Warnings

Roven SuperBloom Glow Defense Cream by is a Otc medication manufactured, distributed, or labeled by Royal Labs Natural Cosmetics, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ROVEN SUPERBLOOM GLOW DEFENSE CREAM- roven superbloom glow defense cream lotion 
Royal Labs Natural Cosmetics, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Roven SuperBloom Glow Defense Cream

Active Ingredients

Zinc Oxide 6%

Titanium Dioxide 3.2%

Use

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

Warnings

For external use only.

Do not use on damaged or broken skin

Stop use and ask doctor if rash occurs

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

Stop use and ask 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.

Roven SuperBloom Glow Defense Cream

Roven SuperBloom Glow Defense Cream

ROVEN SUPERBLOOM GLOW DEFENSE CREAM 
roven superbloom glow defense cream lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69580-998
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.2 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCO GLUCOSIDE (UNII: ICS790225B)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)
COCOS NUCIFERA WHOLE (UNII: 245J88W96L)
PEG-120 GLYCERYL STEARATE (UNII: 6941286E4I)
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)
FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69580-998-01	1 in 1 BOX	01/07/2021
1		29 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/17/2020

Labeler - Royal Labs Natural Cosmetics, Inc. (197478480)

Revised: 1/2021

Document Id: b8bbbfc9-5e79-e9d8-e053-2995a90ab3d0

34390-5

Set id: b4571620-db3d-76e4-e053-2a95a90aec17

Version: 4

Effective Time: 20210112