RENEWALUXE SPF 50 SUNSCREEN cream

RENEWALUXE SPF 50 Sunscreen by

Drug Labeling and Warnings

RENEWALUXE SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Guangzhou Fantesy Biotechnology Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 21.8%

PURPOSE

sunscreen

Uses

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

Warnings

Warnings
For external use only
Do not use on damaged or broken skin.
When using the 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 swallowed, get medical help or contact Poison Control Center right away.

DO NOT USE

Do not use on damaged or broken skin.

KEEP OUT OF REACH OF CHILDREN

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

Directions

Directions Apply liberally 15 minutes before sun exposure Reapply: After 40 minutes of
swimming or sweating
■Immediately after towel drying
■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, regularly use a sunscreen with a Broad Spectrum

SPF value of 15 or higher and other sun protection measures including: Limit time in the sun,
especially from 10a.m. - 2p.m.
■Wear long-sleeve shirts, pants, hats, and sunglasses.
■Children under 6 months: Ask a doctor.

Other information

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

Inactive Ingredients

PRINCIPAL DISPLAY PANEL

No data available

INGREDIENTS AND APPEARANCE

RENEWALUXE SPF 50 SUNSCREEN 
renewaluxe spf 50 sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83447-005
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	21.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
COCONUT OIL (UNII: Q9L0O73W7L)
JOJOBA OIL (UNII: 724GKU717M)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
CERAMIDE 9 (UNII: 88KCS7120E)
TOCOPHEROL (UNII: R0ZB2556P8)
LEMON (UNII: 24RS0A988O)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CETYL DIMETHICONE 45 (UNII: IK315POC44)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83447-005-01	50 mL in 1 BOX; Type 0: Not a Combination Product	06/26/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/26/2024

Labeler - Guangzhou Fantesy Biotechnology Co.,Ltd (619047084)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Fantesy Biotechnology Co.,Ltd		619047084	manufacture(83447-005)