NATURAL TINTED SUN SPF30 titanium dioxide cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Titanium Dioxide (11.7%)
Available from:
aromatica co.
Prescription type:
OTC DRUG
Authorization status:
OTC monograph not final

NATURAL TINTED SUN SPF30- titanium dioxide cream

aromatica co.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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NATURAL TINTED SUN CREAM SPF30

Active Ingredients

Titanium Dioxide (11.7%)

Purpos e

Sunscreen

Keep out of reach of children

Do not swallow. In case of accidental ingestion, get medical help or contact a Poison Control Center

right away.

Us es

Helps prevent sunburn

Warnings

For external use only

Do not use on damaged or broken skin

When using this product

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask doctor if rash or irritation on skin develops and lasts. To ensure skin compatibility,

conduct a skin patch test prior to use.

Store at room temperature

Directions

Shake well before use, and apply the adequate amount on skin. Pat lightly with fingers.

Apply liberally 15 minutes before sun exposure.

Reapply at least every 2 hours.

Use a water-resistant sunscreen if swimming or sweating.

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 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 Ingredients

AQUA, OCTYLDODECANOL, SILICA, JOJOBA ESTER, CAPRYLIC/CAPRIC TRIGLYCERIDE,

POLYHYDROXY STEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, PROPANEDIOL,

IRON OXIDE YELLOW, LAVANDULA ANGUSTIFOLIA EXTRACT, ROSA DAMASCENA

FLOWER EXTRACT, POLYGLYCERYL-2 OLEATE, POLYGLYCERYL-2 STEARATE,

STEARALKONIUM HECTORITE, PROPYLENE CARBONATE, GLYCERIN, ZANTHOXYLUM

PIPERITUM FRUIT EXTRACT, USNEA BARBATA (LICHEN) EXTRACT, PULSATILLA

KOREANA EXTRACT, ARGANIA SPINOSA KERNEL OIL, SORBITAN OLIVATE, IRON OXIDE

RED, SCLEROTIUM GUM, PRUNUS ARMENIACA KERNEL OIL, TOCOPHEROL, OLUS OIL,

IRON OXIDE BLACK, HELIANTHUS ANNUUS SEED OIL, CITRUS AURANTIUM DULCIS

PEEL OIL, CITRUS AURANTIFOLIA OIL, CEDRUS ATLANTICA WOOD OIL, CITRUS LIMON

FRUIT OIL

NATURAL TINTED SUN CREAM SPF30

NATURAL TINTED SUN SPF30

titanium dioxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 533-115

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9 V2JP)

TITANIUM DIOXIDE

5.8 5 g in 50 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

O CTYLDO DECANO L (UNII: 46 1N1O6 14Y)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

HYDRO GENATED JO JO BA O IL, RANDO MIZED (UNII: Q47ST0 2F58 )

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

PO LYHYDRO XYSTEARIC ACID ( 2 3 0 0 MW) (UNII: YXH47AOU0 F)

PRO PANEDIO L (UNII: 59 6 5N8 W8 5T)

FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)

LAVANDULA ANGUSTIFO LIA SUBSP. ANGUSTIFO LIA FLO WERING TO P (UNII: 9 YT4B71U8 P)

RO SA X DAMASCENA FLO WER (UNII: JWB78 P29 5A)

STEARALKO NIUM HECTO RITE (UNII: OLX6 9 8 AH5P)

PRO PYLENE CARBO NATE (UNII: 8 D0 8 K3S51E)

GLYCERIN (UNII: PDC6 A3C0 OX)

ZANTHO XYLUM PIPERITUM FRUIT PULP (UNII: 7PFC2VA251)

USNEA BARBATA (UNII: D6 DVA9 TCAP)

ANEMO NE CERNUA RO O T (UNII: FY35I16 MPL)

ARGAN O IL (UNII: 4V59 G5UW9 X)

SO RBITAN O LIVATE (UNII: MDL271E3GR)

FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)

BETASIZO FIRAN (UNII: 2X51AD1X3T)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

LIME O IL (UNII: UZH29 XGA8 G)

CEDRUS ATLANTICA WO O D O IL (UNII: JEX140 NPX8 )

CITRUS X LIMO N FRUIT O IL (UNII: 0 HNC1J1YED)

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:6 9 533-115-

1 in 1 PACKAGE

0 4/0 1/20 17

1

NDC:6 9 533-115-0 1

50 mL in 1 CONTAINER; Type 0 : No t a Co mbinatio n

aromatica co.

1

NDC:6 9 533-115-0 1

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 4/0 1/20 17

Labeler -

aromatica co. (687505867)

Registrant -

aromatica co. (687505867)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

aro matica co .

6 8 750 58 6 7

ma nufa c ture (6 9 533-115)

Revised: 4/2017

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