SUNNYSCREEN SPF 50- titanium dioxide, zinc oxide lotion

Sunnyscreen SPF 50 by

Drug Labeling and Warnings

Sunnyscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by Supergoop, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

TItanium Dioxide 3.4% Sunscreen

Zinc Oxide 23.8% Sunscreen

PURPOSE

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.

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs or irritation develops and lasts.

WARNINGS

Warnings

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove

For external use only

DOSAGE & ADMINISTRATION

Directions

• Apply liberally and generously 15 minutes before sun exposure.
• Reapply:
• 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 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
• Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

Avena Sativa (Oat) Kernel Flour, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, C9-12 Alkane, Caesalpinia Spinosa Gum, Calendula Officinalis Flower Extract, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride,Cetearyl Alcohol,Chamomila Recutita (Matricaria) Flower Extract, Coco-Caprylate/Caprate, Ethylhexylglycerin, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Haematococcus Pluvialis Extract, Helianthus Annuus (Sunflower) Seed Oil, Hydrolyzed Jojoba Esters, Jojoba Esters, Methyl Dihydroabietate, Myrciaria Dubia Fruit Extract, Polyhydroxystearic Acid, Propanediol, Sea Water, Silica, Sodium Phytate, Sorbitan Stearate, Sorbityl Laurate, Stearic Acid, Water

PRINCIPAL DISPLAY PANEL

Sunnyscreen SPF 50 Lotion for babies+ Kiddos

3 fl. Oz./89ml

INGREDIENTS AND APPEARANCE

SUNNYSCREEN SPF 50 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75936-250
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.4 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	23.8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CHAMOMILE (UNII: FGL3685T2X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
SUNFLOWER OIL (UNII: 3W1JG795YI)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
MYRCIARIA DUBIA FRUIT (UNII: YSW4EM1EKP)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PHYTATE SODIUM (UNII: 88496G1ERL)
SORBITYL LAURATE (UNII: 23XPH3M9LR)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
SHEA BUTTER (UNII: K49155WL9Y)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
WATER (UNII: 059QF0KO0R)
OATMEAL (UNII: 8PI54V663Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75936-250-01	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2019

Labeler - TAYLOR JAMES, LTD. (033381850)

Registrant - TAYLOR JAMES, LTD. (033381850)

Establishment
Name	Address	ID/FEI	Business Operations
GORDON LABORATORIES,INC		008328619	manufacture(75936-250)