SUNSCREEN-LOTION- zinc oxide, titanium dioxide lotion

Sunscreen-Lotion by

Drug Labeling and Warnings

Sunscreen-Lotion by is a Otc medication manufactured, distributed, or labeled by Shanghai Chuangshi Medical Technology (Group) Co., Ltd., Kdc/One Chatsworth, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Titanium Dioxide 3.7% ...... Purpose: Sunscreen

Zinc Oxide 14% ...... Purpose: Sunscreen

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 skin aging caused by the sun.

WARNINGS

(See following 5 SECTIONs)

Do not use

on damaged or broken skin.

Stop use...

if rash occurs.

When using this product

keep out of eyes.

Rinse with water to remove.

... Ask a doctor

if rash occurs.

Keep out of reach of children

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

DIRECTIONS

• Shake well before use
• Apply liberally 15 minutes before sun exposure and as needed.
• Reapply:

·After 40 minutes of swimming or sweating

·Immediately after towel drying

·At least every 2 hours

• Children under 6 months of age: ask a doctor.
• 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 your time in the sun, especially from 10 a.m. - 2 p.m.

·Wear long-sleeved shirts, pants, hats, and sunglasses.

OTHER INFORMATION

• Protect the product in the container from excessive heat and direct sun.

INACTIVE INGREDIENTS

Argania Spinosa Kernel Oil, Auminum Hydroxide, Water (Aqua), Bisbolol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cucumis Sativus (Cucumber) Fruit Extract, Caesalpinia Spinosa Gum, Dicaprylyl Ether, C13-15 Alkane, Carthamus Tinctorius (Safflower) Oleosomes, Caprylyl Glycol, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Helianthus Annuus (Sunflower) Seed Oil, Hydroxyacetophenone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Propanediol, Phenylpropanol, Pongamia Pinnata Seed Extract, Persea Gratissima (Avocado) Oil, Polyglyceryl-10 Mono/Dioleate, Polyhydroxystearic Acid, Rosa Rubiginosa Seed Oil, Stearyl Citrate, Sorbitan Sesquioleate, Silica, Stearic Acid, Sodium Phytate, Trioctyldodecyl Citrate, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, 2-Hexanediol

QUESTIONS

E-mail: webmaster@csigroup.com.cn

Tel: 86-21-31166566

Fax: 86-21-31166568

www.csigroup.com.cn

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN-LOTION 
zinc oxide, titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73557-575
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.037 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.14 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
C13-15 ALKANE (UNII: 114P5I43UJ)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PHYTATE SODIUM (UNII: 88496G1ERL)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
MONOSTEARYL CITRATE (UNII: YWW937R1QR)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)
PHENYLPROPANOL (UNII: 0F897O3O4M)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
STEARIC ACID (UNII: 4ELV7Z65AP)
LEVOMENOL (UNII: 24WE03BX2T)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
POLYGLYCERYL-10 DIOLEATE (UNII: 598RES7AXX)
PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)
WATER (UNII: 059QF0KO0R)
AVOCADO OIL (UNII: 6VNO72PFC1)
CUCUMBER (UNII: YY7C30VXJT)
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
ROSA RUBIGINOSA SEED OIL (UNII: 8M1P49MWAP)
GRAPE SEED OIL (UNII: 930MLC8XGG)
COCONUT OIL (UNII: Q9L0O73W7L)
PROPANEDIOL (UNII: 5965N8W85T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ARGAN OIL (UNII: 4V59G5UW9X)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73557-575-03	67.5 g in 1 BOTTLE; Type 0: Not a Combination Product	09/13/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/13/2023

Labeler - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)

Registrant - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)

Establishment
Name	Address	ID/FEI	Business Operations
Shanghai Chuangshi Medical Technology (Group) Co., Ltd.		546872672	label(73557-575) , pack(73557-575)

Establishment
Name	Address	ID/FEI	Business Operations
Kdc/One Chatsworth, Inc.		118542196	manufacture(73557-575)