SUNSTATION USA SPF-30 SPORT SUNSCREEN- zinc oxide lotion

SunStation USA SPF-30 SPORT SUNSCREEN by

Drug Labeling and Warnings

SunStation USA SPF-30 SPORT SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by RENU LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octyl Methoxy Cinnamate 7.00% Sunscreen

Titanium Dioxide 1.25% Sunscreen

Zinc Oxide 1.25% Sunscreen

Octyl Salicylate 1.00% Sunscreen

Purpose

Octyl Methoxy Cinnamate 7.00% Sunscreen

Titanium Dioxide 1.25% Sunscreen

Zinc Oxide 1.25% Sunscreen

Octyl Salicylate 1.00% Sunscreen

USES

• Helps prevent sunburn.
• higher SPF gives more sunburn protection
• retains SPF after 80 minutes of swimming or sweating
• If used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin aging caused by the sun.

WARNINGS

• 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 or irritation develops and lasts
• Keep out of reach of children.
• If swallowed, get medical help, or contact a Poison Control Center right away.
• If pregnant or breast-feeding, ask a health professional before use.

DIRECTIONS

• Apply liberally 15 minutes before sun exposure and as needed.
• Children under 6 months of age: ask a doctor.
• After 80 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 broad spectrum SPF of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially between 10am and 2pm.
• Wear long sleeve shirts, pants, hats and sunglasses.

OTHER INGREDIENTS

Aloe Barbadensis (Aloe Vera) Leaf Juice, Calendula Officinalis (Marigold) Flower Extract, Caprylyl Glycol, Ceteareth-20, Cetearyl Alcohol, Deionized Water, Dimethicone, Glycerin, Hexylene Glycol, Isocetyl Stearate, Malva Sylvestris (Mallow) Flower Extract, Panax Ginseng Root Extract, Phenoxyethanol, Polyester-7, Neopentyl Glycol, Diheptanoate, Sorbitol, Stearic Acid,

Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine, Tocopheryl Acetate (Vitamin E)

STATEMENT OF IDENTITY

SUNSTATION USA®

SPF-30 SPORT SUNSCREEN

OXYBENZONE & PARABEN FREE

UVA/UVB PROTECTION SUNSCREEN

KEEP OUT OF REACH OF CHILDREN

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

OTHER SAFETY INFORMATION

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

QUESTIONS

QUESTIONS ?

816-686-1345

SUNSTATION PRODUCT LABEL

INGREDIENTS AND APPEARANCE

SUNSTATION USA SPF-30 SPORT SUNSCREEN 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-407
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	11.2 g  in 896 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	63 g  in 896 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	9 g  in 896 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	11.2 g  in 896 g

Inactive Ingredients
Ingredient Name	Strength
ASIAN GINSENG (UNII: CUQ3A77YXI)
MALVA SYLVESTRIS FLOWER (UNII: 12X9JI52BS)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)
COMFREY LEAF (UNII: DG4F8T839X)
SORBITOL (UNII: 506T60A25R)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
WATER (UNII: 059QF0KO0R)
ISOCETYL STEARATE (UNII: 3RJ7186O9W)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYESTER-7 (UNII: 0841698D2F)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
STEARIC ACID (UNII: 4ELV7Z65AP)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-407-01	896 g in 1 CONTAINER; Type 0: Not a Combination Product	02/20/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/20/2024

Labeler - RENU LABORATORIES, INC. (945739449)

Registrant - RENU LABORATORIES, INC. (945739449)

Establishment
Name	Address	ID/FEI	Business Operations
RENU LABORATORIES, INC.		945739449	manufacture(76348-407)