ATTITUDE OCEANLY PHYTO-SUN TINTED - SPF 15 - BROAD SPECTRUM SUNSCREEN- zinc oxide stick

Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum Sunscreen by

Drug Labeling and Warnings

Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum Sunscreen by is a Otc medication manufactured, distributed, or labeled by Attitude DBA 9055-7588 Québec Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Zinc oxide 10%.

Purpose

Sunscreen

Use

Helps prevent sunburn

Warnings

For external use only.

Do not useon damaged or broken skin.

Stop use and ask doctor ifrash occurs.

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

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

Directions

Adults and children older than 6 months.

• Apply generously 15 minutes prior to sun exposure.
• Reapply every 2 hours or after swimming, towel drying, perspiring heavily, or washing .

Inactive ingredients

Helianthus Annuus (sunflower) seed wax, jojoba esters, caprylic/capric triglycerides, isopropyl palmitate, olus oil, isostearyl isostearate, zea mays (corn) starch, ricinus communis (castor) seed oil, polyhydroxystearic acid, glycerin, octyldodecanol, behenyl behenate, butyrospermum parkii (shea) butter, capryloyl glycerin / sebacic acid copolymer, aqua / water / eau, octyldodecyl myristate, sucrose laurate, sucrose stearate, acacia decurrens flower wax, polyglycerin-3, euphorbia cerifera (candelilla) wax, glycogen, rosmarinus officinalis (rosemary) leaf extract, fucus vesiculosus (bladderwrack) extract, iron oxides, isopropyl titanium triisostearate.

Other Information

Store at temperatures below 90 °F.

• Avoid contact of the packaging with water.

PRINCIPAL DISPLAY PANEL - 30 g Tube Label

ATTITUDE™

OCEANLY
PLASTIC FREE BEAUTY™

PHYTO-SUN

tinted cream
SPF 15

BROAD SPECTRUM SUNSCREEN

NPN 80112334

ZINC OXIDE
BLADDERWRACK EXTRACT
PHYTOGLYCOGEN

STICK
30 g | 1 oz.

INGREDIENTS AND APPEARANCE

ATTITUDE OCEANLY PHYTO-SUN TINTED - SPF 15 - BROAD SPECTRUM SUNSCREEN 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61649-068
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
CORN OIL (UNII: 8470G57WFM)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
STARCH, CORN (UNII: O8232NY3SJ)
CASTOR OIL (UNII: D5340Y2I9G)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
GLYCERIN (UNII: PDC6A3C0OX)
OCTYLDODECANOL (UNII: 461N1O614Y)
BEHENYL BEHENATE (UNII: K8NU647RJ0)
SHEA BUTTER (UNII: K49155WL9Y)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)
SUCROSE LAURATE (UNII: 05Q7CD0E49)
SUCROSE STEARATE (UNII: 274KW0O50M)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
CANDELILLA WAX (UNII: WL0328HX19)
GLYCOGEN (UNII: 309GSC92U1)
ROSEMARY (UNII: IJ67X351P9)
FUCUS VESICULOSUS (UNII: 535G2ABX9M)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61649-068-01	30 g in 1 TUBE; Type 0: Not a Combination Product	01/25/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	01/25/2023

Labeler - Attitude DBA 9055-7588 Québec Inc. (201137051)

Establishment
Name	Address	ID/FEI	Business Operations
Attitude DBA 9055-7588 Québec Inc.		204307099	manufacture(61649-068) , label(61649-068) , pack(61649-068) , analysis(61649-068)