SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15

Drug Details [pdf]

SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15- ethylhexyl methoxycinnamate, octocrylene gel
Guangzhou Tata Biotechnology Co., Ltd.

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SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15

Ethylhexyl Methoxycinnamate 7.5%

Octocrylene 5%

Sunscreen

protect lips from damaging UVA and UVB rays.

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

Step 1:Saueeze tube.

Step 2:Apply liberally and evenly to lips 15 to 20 minutes before exposure to the sun.

Step3:Reapply after periods of swimming exercise and towel drying or as required.

Protect this product from excessive heat anddirect sun.
Sun alert: Limiting sun exposure, wearing protective clothing,and using sunscreens may reduce the risk of skin aging, skin cancer,and other harmful effects of the sun.

Ethylhexyl Palmitate, Polyisobutene,Petrolatum,Microcrystalline Wax,Hydrogenated Styrene/lsoprene Copolymer,PentaerythritylTetra-Di-T-ButylHydroxyhydrocinnamate,Beeswax, Synthetic Wax, Tocopheryl Acetate, Tridecyl Trimellitate,Simmondsia Chinensis (Jojoba) Seed Oil,Macadamia Integrifolia Seed Oil, Limnanthes Alba(Meadowfoam)Seed Oi,Butyrospermum Parkii (Shea) Butter, Hydrogenated Coconut Oil,Phenoxyethanol,Ethylhexylglycerin,Fragrance,FD&C YELLOW NO.5(C119140),TheobromaCacao(Cocoa)Extract,

Dextrin,Phytosteryl/OctyldodecylLauroyl, Glutamate,Tocopherol

You can email us at info@redi-usa.com for more help!

labeling

SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15
ethylhexyl methoxycinnamate, octocrylene gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84066-103
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 mg in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ICODEXTRIN (UNII: 2NX48Z0A9G)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
COCOA (UNII: D9108TZ9KG)
YELLOW WAX (UNII: 2ZA36H0S2V)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
STYRENE/ISOPRENE COPOLYMER (28:72; 210000 MW) (UNII: H58HX2GWJ5)
POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
MACADAMIA OIL (UNII: 515610SU8C)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 84066-103-01	10 mL in 1 TUBE; Type 0: Not a Combination Product	07/02/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	07/02/2024	12/31/2024

Labeler - Guangzhou Tata Biotechnology Co., Ltd. (699605102)

Registrant - Guangzhou Tata Biotechnology Co., Ltd. (699605102)

Name	Address	ID/FEI	Business Operations
Establishment
Guangzhou Tata Biotechnology Co., Ltd.		699605102	manufacture(84066-103)

Revised: 11/2024

Document Id: 28086872-d8c3-0027-e063-6294a90a6259

Set id: 1c32b019-a038-eb61-e063-6394a90a45f2

Version: 3

Effective Time: 20241129

SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15

SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15 by

Drug Labeling and Warnings

Drug Details [pdf]

SUNSCREEN LIP PROTECTIONBROAD SPECTRUM SPF 15