OI LIN DEEP MOISTURE SUNSCREEN SPF 30- sunscreen, titanium dioxide, zinc oxide lotion

OI LIN DEEP MOISTURE SUNSCREEN SPF 30 by

Drug Labeling and Warnings

OI LIN DEEP MOISTURE SUNSCREEN SPF 30 by is a Otc medication manufactured, distributed, or labeled by Sunrider Manufacturing L.P.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

USES

• Helps prevent sunburn
• if used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun

DOSAGE & ADMINISTRATION

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 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 months: Ask a doctor.

ASK DOCTOR

CHILDREN UNDER 6 MONTHS OF AGE:  CONSULT A DOCTOR BEFORE USE.

Stop use and ask a doctor if rash occurs.

WARNINGS

WARNING:  FOR EXTERNAL USE ONLY

Do not use on damaged or 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 prouct is swallowed, get medical help or conatct a Poison Control Center right away.

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.

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

TITANIUM DIOXIDE 13.9%

ZINC OXIDE 3.9%

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OI LIN DEEP MOISTURE SUNSCREEN SPF 30 
sunscreen, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62191-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	139 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	39 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINUM OXIDE (UNII: LMI26O6933)
ARABICA COFFEE OIL (UNII: IK55HKE887)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
AVOCADO OIL (UNII: 6VNO72PFC1)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BISABOLOL OXIDE A (UNII: 16AE65F94Y)
BISABOLOL OXIDE B, (-)- (UNII: S32G48306Y)
CERAMIDE 3 (UNII: 4370DF050B)
COMFREY ROOT (UNII: M9VVZ08EKQ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE PEG-10 PHOSPHATE (UNII: O7Q5NJ7X88)
DIMETHICONOL (41 MPA.S) (UNII: 343C7U75XW)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
Glycerin (UNII: PDC6A3C0OX)
EDETATE TRISODIUM (UNII: 420IP921MB)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HEXYLDECANOL (UNII: 151Z7P1317)
HORSE CHESTNUT (UNII: 3C18L6RJAZ)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
LAMINARIA DIGITATA (UNII: 15E7C67EE8)
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)
LAVANDIN OIL (UNII: 9RES347CKG)
LEVOMENOL (UNII: 24WE03BX2T)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)
MENTHA PULEGIUM (UNII: 5Q6Y7K4846)
METHICONE (20 CST) (UNII: 6777U11MKT)
OAT (UNII: Z6J799EAJK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PLANTAGO OVATA SEED (UNII: UD50RBY30F)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ROSEMARY (UNII: IJ67X351P9)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TOCOPHEROL (UNII: R0ZB2556P8)
THYME OIL (UNII: 2UK410MY6B)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62191-022-05	1 in 1 PACKAGE	12/04/2018	12/31/2022
1		50 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/04/2018	12/31/2022

Labeler - Sunrider Manufacturing L.P. (786951475)

Registrant - Sunrider Manufacturing L.P. (786951475)

Establishment
Name	Address	ID/FEI	Business Operations
Sunrider Manufacturing L.P.		786951475	manufacture(62191-022)