DALLAS JAMES SKINCARE CO. SPF 50 SUNSCREEN cream

DALLAS JAMES SKINCARE CO. SPF 50 Sunscreen by

Drug Labeling and Warnings

DALLAS JAMES SKINCARE CO. 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 24%

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

① For external use only.

② When using this product keep out of eyes.

DO NOT USE

Do not use on damaged or broken skin.

KEEP OUT OF REACH OF CHILDREN

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

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

Other information

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 10 a.m.-2 p.m.
■ wear long-sleeve shirts, pants, hats, and sunglasses.
■children under 6 n mornths: ask a doctor.

Inactive Ingredients

aqua, aloe barbadensis leaf juice, caprylic/ capric triglycerides, sorbitan stearate, polyglyceryl-4 isostearate, hexyl laurate, cetyl
dimethicone, helianthus annuus (sunflower) seed oil, simmondsia chinensis (jojoba) seed oil, citrullus lanatus
(watermelon) fruit extract, rubus chamaemorus (cloudberry) fruit extract, niacinamide, centella asiatica extract, ceramide NP,
tocopherol (vitamin e), citrus limon (lemon) fruit extract, sodium hyaluronate, watermelon essential oil, potassium sorbate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DALLAS JAMES SKINCARE CO. SPF 50 SUNSCREEN 
dallas james skincare co. spf 50 sunscreen cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83447-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	24 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
COCONUT OIL (UNII: Q9L0O73W7L)
LEMON (UNII: 24RS0A988O)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
TOCOPHEROL (UNII: R0ZB2556P8)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
JOJOBA OIL (UNII: 724GKU717M)
WATERMELON (UNII: 231473QB6R)
NIACINAMIDE (UNII: 25X51I8RD4)
CERAMIDE NS (UNII: V7M2259XJM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83447-010-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/18/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/18/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Fantesy Biotechnology Co.,Ltd		619047084	manufacture(83447-010)