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NDC 69520-0525-00 Docs SKINCARE NATURAL SUNSCREEN SPF30 60; 60 mg/mL; mg/mL Details

Docs SKINCARE NATURAL SUNSCREEN SPF30 60; 60 mg/mL; mg/mL

Docs SKINCARE NATURAL SUNSCREEN SPF30 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Doc's Skincare LLC. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	69520-0525
Product ID	69520-525_47f4f989-fab7-6576-e054-00144ff8d46c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Docs SKINCARE NATURAL SUNSCREEN SPF30
Proprietary Name Suffix	n/a
Non-Proprietary Name	TITANIUM DIOXIDE, ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	60; 60
Active Ingredient Units	mg/mL; mg/mL
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Doc's Skincare LLC
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2022-12-31

Package

Package Images

NDC 69520-0525-00 (69520052500)

Pricing Information	N/A
NDC Package Code	69520-525-00
Billing NDC	69520052500
Package	1 BOTTLE in 1 CARTON (69520-525-00) / 118 mL in 1 BOTTLE
Marketing Start Date	2017-02-06
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL fb3310a8-9522-46e1-8b51-3f9b3798ea52 Details

DRUG FACTS

Active Ingredients

Titanium Dioxide 6.0%

Zinc Oxide 6.0%

Purpose

Sunscreen

USES

Helps prevent sunburn.
Higher SPF values gives more protection.

WARNINGS

For external use only.
Keep out of eyes - rinse with water to remove.

Stop use and consult physician

if irritation or rash develops.

Keep out of reach of children.

DIRECTIONS

Apply every to skin immediately prior to sun exposure, wearing protective clothing and sunscreen may reduce the risks of skin aging, skin cancer and other harmfuleffects of the sun.

ADDITIONAL INFORMATION

This is a high sun protection product.

SUN ALERT: Limiting sun exposure, wearing protective clothing and sunscreen may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.

OTHER INGREDIENTS:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Leaf Extract, daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Ethylhexyl Palmitate, Glyerin, G;ycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Lecithin, Phenoxyethanol, Prunus Amygdalus Dulcis (Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Theobrama Cacao (Cocoa) Butter, Tocopheryl Acetate (Vitamin E), Xanthan Gum

Product Label

INGREDIENTS AND APPEARANCE

DOCS SKINCARE NATURAL SUNSCREEN SPF30

titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69520-525
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARROT (UNII: L56Z1JK48B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN OIL (UNII: 241ATL177A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALMOND OIL (UNII: 66YXD4DKO9)
SESAME OIL (UNII: QX10HYY4QV)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69520-525-00	1 in 1 CARTON	02/06/2017
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	01/08/2015

Labeler - Doc's Skincare LLC (060117994)

Revised: 2/2017

Document Id: 47f4f989-fab7-6576-e054-00144ff8d46c

Set id: fb3310a8-9522-46e1-8b51-3f9b3798ea52

Version: 2

Effective Time: 20170207